| 1. |
- Björling, Gunilla, Docent
(författare)
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Long-Term Tracheostomy : Outcome, Cannula care, and Material Wear
- 2007
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Do people with long-term tracheostomy need hospital care? Which cleaning method is most appropriate for decontamination of inner cannulae? Are tracheostomy tubes changed for rational reasons? There is clearly a lack of evidence based research in this field and the clinical guidelines available are often based on local practice. A tracheostomy is a created opening in trachea to facilitate breathing. It is a direct entry to the deeper airways, e.g. for micro-organisms causing a potential risk for lung infections. Indications for long-term tracheostomy can be, e.g. upper airway obstruction, malformations, or chronic hypoventilation, when ventilation via nasal mask is not possible. The research of the present thesis was conducted at the National Respiratory Centre (NRC) at Danderyd Hospital in Stockholm, Sweden. This unit opened in 1982, with the expressed goal of supporting outpatients with long-term tracheostomy. The overall aims of the thesis were to evaluate the outcome of patients with long-term tracheostomy and to conduct evidence based studies concerning their care.A comparison was made for the number of days in hospital care during the 2-year periods before and after the tracheostomy was established. The life expectancy of the general population and the observed life span of a cohort of tracheostomized patients from the start of NRC in 1982 were also compared. Interestingly enough, the need for hospital care was unchanged despite of the tracheostomy. The patients’ observed life spans were remarkably high and for many patients not lower than the life expectancy of Swedish people in general.To find a practical and safe decontamination method for inner cannulae we compared two different cleaning methods; detergent followed by chlorhexidine-alcohol, or detergent alone. Samples for bacterial culture were taken before and after cleaning and the numbers of bacteria colonies were counted. The effectiveness of both cleaning methods was greater than expected and the results showed a nearly total elimination of organisms. Thus, the methods investigated were equivalent in achieving decontamination.The duration of use in our unit for polymeric tracheostomy tubes, i.e. silicone (Si), polyvinyl chloride (PVC), and polyurethane (PU) was determined and compared. We found, that Si tubes were used for longer periods (three months) than tubes made of PU or PVC (both two months).Whether or not surface changes could be observed on the tracheostomy tubes after 30 days’, three and six months’ exposure in the trachea were investigated in collaboration with the Royal Institute of Technology and Sophiahemmet University College in Stockholm, Sweden. The analyzing methods were Scanning Electron Microscopy, Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy, and Differential Scanning Calorimetry. All tubes, except one, showed changes in the surface after 30 days’ exposure. The surface changes had progressed significantly after three and six months' exposure, compared to the changes detected after 30 days. The SF-36 questionnaire and a study specific questionnaire were used to describe the patients’ health-related quality of life and experiences of long-term tracheostomy. The results show that all patients were satisfied with their tracheostomy and demonstrated a numerically mean mental health status score above that of the general population.In summary, long-term tracheostomy does not increase the need for hospital care nor does it reduce a patient’s life span. Cleaning the tracheostomy inner cannula with detergent and water is sufficient to achieve decontamination. Si tracheostomy tubes are used longer compared to those made of PVC or PU. The polymeric material investigated suffered evident surface changes after 30 days’ use. Clinical use of polymeric tracheostomy tubes beyond three months cannot be recommended, as we found extensive surface changes and degradation of the polymeric chains. All patients were, in general content, with their tracheostomy. The findings from the present thesis contribute to making the care of long-term tracheostomized patients’ evidence based.
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| 2. |
- Gripewall, E., et al.
(författare)
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Intensive Care Nurses’ Experiences of Caring during the Organ Donor Process in Sweden : a Qualitative Study
- 2022
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Ingår i: International Journal of Caring Sciences. - Hellas : Athens Alexander Technological Educational Institu. - 1791-5201 .- 1792-037X. ; 15:2, s. 720-726
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Tidskriftsartikel (refereegranskat)abstract
- Background: The organ donor process is challenging, not at least for intensive care nurses. The situation changes radically, from intensively working to save the patient’s life to instead caring for the donor patient’s organs so that those, in turn, can save another patient’s life. The donation process challenges nurses’ view on what dignified caring at end-of-life entails. The inner core of caring comprises love, mercy and compassion. Dignified caring is related to treating the patient as a unique human being and respecting human value, rooted in the theory of caritative caring that is the framework for this study. Aim: The aim was to illuminate intensive care nurses’ experiences of caring during the organ donor process, from a caring science perspective.Methodology: A descriptive research design including inductive qualitative content analysis of interviews with twelve intensive care nurses in Sweden about their experiences of caring during the donor process.Results: The theme The complexity of caring during the organ donor process with two categories and five subcategories was generated. Intensive care nurses experienced caring during the donor process as being complex in relation to the potential donor patient and patient’s family as well as communication, teamwork and organization. Caring affects not only the patient and families, but also the nurses and receivers of the donated organs. Intensive care nurses perceive the other’s life situation as if it were their own and recognize the importance of shared humanity.
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| 3. |
- Hansson, Julia, et al.
(författare)
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The Healthcare Staffs’ Perception of Parents’ Participation in Critical Incidents at the PICU, a Qualitative Study
- 2021
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Ingår i: Nursing Reports. - : MDPI. - 2039-439X .- 2039-4403. ; 11:3, s. 680-689
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Tidskriftsartikel (refereegranskat)abstract
- Background: Internationally, there are very few guidelines regarding how near relations can be taken care of on a children’s intensive care unit. Despite knowledge about the positive effects of parental presence, staff frequently reject parents out of insecurity. This study aimed to investigate health professionals’ understanding of letting parents be present throughout critical situations. A qualitative method with semi-structured interviews was used to answer the aim of his study. Nine persons participated in the study, both physicians and nurses. The result showed that health professionals’ main view is that parents’ presence is positive. However, their presence often has lower priority than the medical focus of the child and the health professionals’ concern of failure. Conclusion: Health professionals have the power to decide if parents can be present in critical situations. Only when a parent demands to be present does that demand beat the decisions made by health professionals. Lack of resources within the team and fear of parents becoming a disturbance or a distraction are cited as the primary reasons not to let parents be present.
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| 4. |
- Manhica, Hélio, et al.
(författare)
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Promoting sustainable health and wellbeing for pregnant adolescents in Uganda – A qualitative case study among health workers
- 2021
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Ingår i: International Journal of Africa Nursing Sciences. - : Elsevier. - 2214-1391. ; 14, s. 1-7
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Tidskriftsartikel (refereegranskat)abstract
- Background: Adolescent pregnancy is a global health problem. In Uganda, the rate of teenage pregnancies is approximately 25% and these are associated with both poor maternal- and perinatal health outcome.Objective: This qualitative case study aimed to examine health workers’ experiences of promoting sustainable health and well-being for pregnant adolescent girls in Uganda.Method: A qualitative study design was used. Data was collected through semi-structured interviews of four health workers working for a Non-Government Organization (NGO) based in Uganda. Data was inductively analyzed by content analysis.Result: Three categories emerged: social structure, organization’s work – rehabilitation and therapy, and outcome. Healthcare workers worked with health promotion using a person-centered approach, emphasizing therapies and empowerment strategies and an overall faith-based approach. Furthermore, the result showed that girls were abandoned by their families when entering the center, but with help from the NGO they increased their understanding of the girls situation, due to resettlement of plan and follow up made by the health workers.Conclusion: Health workers can promote health and well-being among pregnant adolescent by applying person-centered care, including therapies and empowerment strategies by a faith-based approach. Social structures and families should be encouraged to provide support to pregnant adolescent girls.
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| 5. |
- Mattsson, Janet, Docent, Ph.D, 1967-, et al.
(författare)
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Challenges in Nursing Care of Children With Substance Withdrawal Syndrome in the PICU
- 2022
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Ingår i: Sage Open Nursing. - : Sage Publications. - 2377-9608. ; 8
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Substance withdrawal is one of the most common advert events in the Pediatric Intensive Care Unit (PICU), as the administration of potent opiates and sedative drugs is frequently performed several times each day.Objectives: The present study explored the challenges in nursing care of children with substance withdrawal syndrome inthe PICU.Method: The study has an explorative and descriptive semi-structured qualitative interview design, with a strategic selection of informants. It was conducted at one out of three pediatric intensive care units in Sweden.Results: Three different main themes were identified describing the different challenges regarding withdrawal symptoms: monitor the child’s interest, work with structured support, and understand the observation.Conclusions: There is a discrepancy between the medical perspective and the nursing care perspective regarding children in PICU suffering from withdrawal syndrome. The lack of joint guidelines, language, and nursing diagnoses may lead to subjective evaluations and increase suffering for these children.
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| 6. |
- Mattsson, Janet, Docent, Ph.D, 1967-, et al.
(författare)
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Delirium, How Do Nurses Cope In The PICU
- 2022
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Ingår i: Pediatric Critical Care Medicine. - : Lippincott Williams & Wilkins. - 1529-7535 .- 1947-3893. ; 23:Supplement 1 11S
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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| 7. |
- Mattsson, Janet, Docent, Ph.D, 1967-, et al.
(författare)
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Nurses’ Experiences of Caring for Patients With Suspected or Confirmed COVID-19 in the Initial Stage of the Pandemic
- 2022
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Ingår i: Sage Open Nursing. - : Sage Publications. - 2377-9608. ; 8, s. 1-11
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Nursing staff have faced various challenges during the global pandemic of COVID-19 such as nursing shortages. The great number of COVID-19 patients requiring hospitalization placed heavy demands on healthcare staff to maintain patient safety and to work according to constantly changing guidelines to prevent the spread of infection.Objective: The objective was to describe nurses’ experiences of caring for patients with suspected or confirmed COVID-19 in the initial phase of the pandemic.Methods: The study has a qualitative design. Semi-structured interviews were conducted with seven nurses in primary care and hospital care during the initial stage of the pandemic. Qualitative content analysis with an inductive approach was used.Results: The nurses expressed that the working routines changed very quickly at the onset of the pandemic. A triage system was implemented to care for patients with symptoms of COVID-19 to prevent transmission between patients. A major change was the constant use of personal protective equipment in patient care. The nurses also experienced a sense of inadequacy regarding the care of the patients and became emotionally affected and exhausted.Conclusion: The nurses experienced that many patients worsened clinically, leading to exhausting and difficult nursing care situations. They also experienced increasing responsibility since new protective equipment and procedures needed to be quickly implemented according to frequently changing recommendations, causing the nurses to feel uncertain about how to maintain patient safety. Support from colleagues was crucial to cope throughout the initial stage of the pandemic.
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| 8. |
- Mattsson, Janet, Docent, Ph.D, 1967-, et al.
(författare)
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Quality Of Life in Children With Home Mechanical Ventilation – A Scoping Review
- 2022
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Ingår i: Sage Open Nursing. - : Sage Publications. - 2377-9608. ; 8, s. 1-12
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Home mechanical ventilation is an established method to support children suffering from chronic respiratory insufficiency, still more research is needed regarding mechanically ventilated children’s and adolescents’ quality of life (QoL). Therefore, the aim of this scoping review was to explore research regarding QoL and lived experience of children and adolescents with home mechanical ventilation. Methods: A scoping review with systematic searches for research studies published between year 2000–2020 was performed in Cinahl, Medline, and PubMed. Studies that met the inclusion criteria were quality assessed and a thematic analysis was performed.Results: In total, ten articles were quality assessed and included in the results. Four themes emerged: Children’s self-reported QoL, Parents’ perception and parent-proxy report, Differences between the child’s and parent’s perception, and challenges in daily life. Children with home mechanical ventilation reported a lower QoL than healthy children and children with other chronic diseases. Generally, parents rate their child’s QoL lower than the children themselves.Conclusion: This is the first literature review focusing on HMV in the paediatric population. It is clear that HMV does not only affect the treated child or adolescent but also the whole family. It is important to regularly measure and evaluate QoL in children and adolescents with
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| 9. |
- Alden-Joyce, Tara, et al.
(författare)
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Tanzanian Nursing Students' Experiences of Student Exchange in Sweden : A Qualitative Case Study
- 2023
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Ingår i: Sage Open Nursing. - : Sage Publications. - 2377-9608. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionNeeds within healthcare are changing and nurses require new skills and knowledge in global nursing. Student exchange programs in global contexts provide an opportunity to develop the necessary skills. ObjectiveThe aim of this study was to describe Tanzanian nursing students' experiences of student exchange in Sweden. MethodsA qualitative design was used for this empirical study. Semistructured interviews were conducted with six Tanzanian nursing students who had participated in student exchange in Sweden. The participants were recruited by purposeful sampling. Inductive reasoning and qualitative content analysis were applied. ResultsFour main themes were formed; new roles, experience a new culture, establish new competencies, and global work ambitions. The findings revealed that the students experienced new approaches in Sweden, giving them new competencies and understanding. Furthermore, they increased their global perspectives on nursing and interest in working with global health issues, but they also experienced challenges in the new environment. ConclusionThe present study showed that Tanzanian nursing students benefitted from their student exchange, both personally, as well as for their future careers as nurses. More research is needed in examining nursing students from low-income countries participating in student exchange in high-income countries.
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| 10. |
- Anderberg, Peter, et al.
(författare)
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Analyzing nursing students’ relation to electronic health and technology as individuals and students and in their future career (the ENURSED study) : Protocol for a longitudinal study
- 2019
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Ingår i: Journal of Medical Internet Research. - : Journal of Medical Internet Research. - 1438-8871. ; 21:10
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Tidskriftsartikel (refereegranskat)abstract
- Background: The nursing profession has undergone several changes in the past decades, and new challenges are to come in the future; patients are now cared for in their home, hospitals are more specialized, and primary care will have a key role. Health informatics is essential in all core competencies in nursing. From an educational perspective, it is of great importance that students are prepared for the new demands and needs of the patients. From a societal point of view, the society, health care included, is facing several challenges related to technological developments and digitization. Preparation for the next decade of nursing education and practice must be done, without the advantage of certainty. A training for not-yet-existing technologies where educators should not be limited by present practice paradigms is desirable. This study presents the design, method, and protocol for a study that investigates undergraduate nursing students’ internet use, knowledge about electronic health (eHealth), and attitudes to technology and how experiences of eHealth are handled during the education in a multicenter study. Objective: The primary aim of this research project is to describe the design of a longitudinal study and a qualitative substudy consisting of the following aspects that explore students’ knowledge about and relation to technology and eHealth: (1) what pre-existing knowledge and interest of this area the nursing students have and (2) how (and if) is it present in their education, (3) how do the students perceive this knowledge in their future career role, and (4) to what extent is the education capable of managing this knowledge? Methods: The study consists of two parts: a longitudinal study and a qualitative substudy. Students from the BSc in Nursing program from the Blekinge Institute of Technology, Karlskrona, Sweden, and from the Swedish Red Cross University College, Stockholm/Huddinge, Sweden, were included in this study. Results: The study is ongoing. Data analysis is currently underway, and the first results are expected to be published in 2019. Conclusions: This study presents the design of a longitudinal study and a qualitative substudy. The eHealth in Nursing Education eNursEd study will answer several important questions about nursing students’ attitudes toward and use of information and communications technology in their private life, their education, and their emerging profession. Knowledge from this study will be used to compare different nursing programs and students’ knowledge about and relation to technology and eHealth. Results will also be communicated back to nursing educators to improve the teaching of eHealth, health informatics, and technology. ©Peter Anderberg, Gunilla Björling, Louise Stjernberg, Doris Bohman.
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| 11. |
- Andersson, Ewa K., 1972-, et al.
(författare)
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Self-Reported eHealth literacy among nursing students in Sweden and Poland : The eNursEd cross-sectional multicentre study
- 2023
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Ingår i: Health Informatics Journal. - : Sage Publications. - 1460-4582 .- 1741-2811. ; 29:4
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Tidskriftsartikel (refereegranskat)abstract
- This study aimed to provide an understanding of nursing students’ self-reported eHealth literacy in Sweden and Poland. This cross-sectional multicentre study collected data via a questionnaire in three universities in Sweden and Poland. Descriptive statistics, the Spearman’s Rank Correlation Coefficient, Mann–Whitney U, and Kruskal–Wallis tests were used to analyse different data types. Age (in the Polish sample), semester, perceived computer or laptop skills, and frequency of health-related Internet searches were associated with eHealth literacy. No gender differences were evidenced in regard to the eHealth literacy. Regarding attitudes about eHealth, students generally agreed on the importance of eHealth and technical aspects of their education. The importance of integrating eHealth literacy skills in the curricula and the need to encourage the improvement of these skills for both students and personnel are highlighted, as is the importance of identifying students with lacking computer skills.
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| 12. |
- Antoniadou, Irini, et al.
(författare)
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Moving from Participation towards Partnership in Nursing Care
- 2019
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Ingår i: Anaesthesia & Surgery Open Access Journal. - USA : Iris Publishers. ; 1:3, s. 1-8
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Tidskriftsartikel (refereegranskat)abstract
- Background: Meeting with health care gets short before and after the operation. The difficulty at the day surgery is that preparation and information take place in close proximity to the operation. Health professionals must not only take care of the child during the medical visit, but also of the accompanying parent, too. Parents’ participation in the perioperative care, sometimes unable to attend.Aim: This study aims to investigate how parental involvement in the perioperative a process can be facilitated.Method: A qualitative design based on observations and interviews with semi structured questions with open answers. Results: The results conveyed involvement in the child’s perioperative process in diverse ways and to a different depth. This is highlighted in the theme Allowed with the under themes Security and Being accepted. However, the theme Exclusion with the under-theme Rejection revealed a non-caring approach where no caring relation could be established. Quotes from the transcribed material are used to highlight the results.Conclusion: The study’s findings confirm earlier studies in the perspective that information is of central importance in enabling parents to be involved in the perioperative process. The results showed that parents’ involvement in the perioperative process is a prerequisite for creating safety in the child and reducing concerns in connection with the operation. Parental involvement may be hindered by a conventional approach that does not include the child’s perspective.
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| 13. |
- Backman, Sara, et al.
(författare)
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Material Wear of Polymeric Tracheostomy Tubes : A Six-Month Study
- 2009
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Ingår i: The Laryngoscope. - : Wiley. - 0023-852X .- 1531-4995. ; 119:4, s. 657-664
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The objectives were to study long-term material wear of tracheostomy tubes made of silicone (Si), polyvinyl chloride (PVC), and polyurethane (PU) after 3 and 6 months of clinical use. Study Design: The study has a prospective and comparative design. Methods: Nineteen patients with long-term tracheostomy, attending the National Respiratory Center in Sweden, were included, n = 6 with Si tubes, n = 8 with PVC tubes, and n = 5 with PU tubes. The tubes were exposed to the local environment, in the trachea for 3 and 6 months and analyzed by scanning electron microscopy, attenuated total reflectance Fourier transform infrared spectroscopy, and differential scanning calorimetry. Results: All tubes revealed severe surface changes. No significant differences were established after 3 or 6 months of exposure between the various materials. The changes had progressed significantly after this period, compared to previously reported changes after 30 days of exposure. The results from all analyzing techniques correlated well. Conclusions: All tubes, exposed in the trachea for 3-6 months, revealed major degradation and changes in the surface of the material. Polymeric tracheostomy tubes should be changed before the end of 3 months of clinical use.
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| 14. |
- Björling, Gunilla, Docent, et al.
(författare)
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A retrospective survey of outpatients with long-term tracheostomy
- 2006
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Ingår i: Acta Anaesthesiologica Scandinavica. - : Wiley-Blackwell. - 0001-5172 .- 1399-6576. ; 50:4, s. 399-406
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Tidskriftsartikel (refereegranskat)abstract
- Background: The Respiratory Unit (RU) at Danderyd University Hospital opened in 1982, with the expressed goal of supporting outpatients with long-term tracheostomy. The primary aim of this retrospective study in tracheostomized patients was to compare the need for hospital care in the 2-year period before and after the tracheostomy.Methods: Data were collected from patient medical records at the RU, from the National Board of Health and Welfare, Sweden and from the Official Statistics of Sweden. The subjects were RU patients in 1982 (Group 1, n = 27) and in 1997 (Group 2, n = 106) with long-term tracheostomy surviving at least 4 years after the tracheostomy.Results: Both groups had few and unchanged needs for hospital care after tracheostomy. They spent ≥ 96% of their time out of hospital. In 1997, (group 2) the number of patients, diagnoses and need for home mechanical ventilation had increased. Life expectancy was assessed for patients in Group 1. Data showed that they lived as long as an age-matched and gender-adjusted control cohort.Conclusions: Long-term tracheostomy may not increase the need for hospital care and does not reduce life expectancy. These clinical observations were made in a setting where patients had regular access to a dedicated outpatient unit.
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| 15. |
- Björling, Gunilla, Docent, et al.
(författare)
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Clinical use and material wear of polymeric tracheostomy tubes
- 2007
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Ingår i: The Laryngoscope. - : Lippincott Williams & Wilkins. - 0023-852X .- 1531-4995. ; 117:9, s. 1552-1559
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: The objectives were to compare the duration of use of polymeric tracheostomy tubes, i.e., silicone (Si), polyvinyl chloride (PVC), and polyurethane (PU), and to determine whether surface changes in the materials could be observed after 30 days of patient use. METHODS: Data were collected from patient and technical records for all tracheostomized patients attending the National Respiratory Center in Sweden. In the surface study, 19 patients with long-term tracheostomy were included: six with Bivona TTS Si tubes, eight with Shiley PVC tubes, and five with Trachoe Twist PU tubes. All tubes were exposed in the trachea for 30 days before being analyzed by scanning electron microscopy (SEM) and attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR). New tubes and tubes exposed in phosphate-buffered saline were used as reference. RESULTS: Si tubes are used for longer periods of time than those made of PVC (P < .0001) and PU (P = .021). In general, all polymeric tubes were used longer than the recommended 30-day period. Eighteen of the 19 tubes exposed in patients demonstrated, in one or more areas of the tube, evident surface changes. The morphologic changes identified by SEM correlate well with the results obtained by ATR-FTIR. CONCLUSIONS: Si tracheostomy tubes are in general used longer than those made of PVC and PU. Most of the tubes exposed in the trachea for 30 days suffered evident surface changes, with degradation of the polymeric chains as a result.
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| 16. |
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| 17. |
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| 18. |
- Björling, Gunilla, Docent, et al.
(författare)
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Livskvalitet hos äldre människor med utvecklingsstörning
- 2001
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- Syftet med skriften var att ta fram en rapport om dagsläget när det gäller internationell forskning om äldre med intellektuella funktionshinder. Forskningen som redovisas är inriktad mot livskvalitet, d v s det positiva åldrandet. Resultatet redovisas med följande indelning: Livskvalitet - boende. Livskvalitet - livsstil. Livskvalitet - social förmåga. Livskvalitet - fritid. Hälsa. Åldrande föräldrar till intellektuellt funktionshindrade.
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| 19. |
- Björling, Gunilla, Docent
(författare)
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Long-term tracheostomy : How to do it
- 2009
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Ingår i: Breathe: continuing medical education for respiratory professionals. - Lausanne, Switzerland : European Respiratory Society. - 1810-6838. ; 5:3, s. 204-213
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Tidskriftsartikel (refereegranskat)abstract
- The overall aim for long-term tracheostomy care is to help those with respiratory failure to achieve a high-quality active life. A long-term tracheostomy does not necessarily mean an increased need for hospital care. With an optimally fitted tracheostomy tube, patient and staff education and regular follow-ups, serious complications can be avoided. This article describes predictors of good long-term tracheostomy care, such as tube selection, indications of change and follow-up.
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| 20. |
- Björling, Gunilla, Docent
(författare)
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Material Wear of Medical Technical Products : Impact on patient safety
- 2018
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Konferensbidrag (refereegranskat)abstract
- The use of a central venous catheters (CVC) always involves an increased risk of infection and thrombotic complications, subsequently increasing patient suffering, prolonged care and health care related costs. One contributing cause of infection is that the surface of the catheter is quickly colonized by bacteria, forming a biofilm, hard to reach by and/or resistant to antibiotics and the patient’s immune defense system. Catheter related thrombosis may also promote colonization of microbes on the fibrin sheet at the surface, and at the same time impact on CVC functionality by lumen occlusion or, in a rare worst-case scenario – cause life threatening embolic events. Coatings with silver or metal alloys can reduce the risk for complications. Our research group have previously identified a correlation between material degradation in medical devices used in patients and exposure time and infections. This talk will discuss the impact of material degradation of different types of CVCs used for patients undergoing chemotherapy against breast cancer. The results from an evaluation study of a anti infectious noble metal alloy coated CVC compared with an uncoated CVC for tolerability (Adverse Events, AEs), performance and noble metal durability on the surface will also be discussed.
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| 21. |
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| 22. |
- Björling, Gunilla, Docent, et al.
(författare)
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Risk Evaluation of Therapy Medical Devices and Implants for Increased Patient Safety : REMISS Horizon 2020 Research and Innovation Action
- 2017
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Konferensbidrag (refereegranskat)abstract
- Current knowledge in the area of medical devices remains insufficiently complete, and many of the established test methods and international standards (ISO (International Organization for Standardization) standards) open up to individual interpretation on how the test should be performed and the results reported. Treating long-term diseases such as cancer imposes a stringent sequence of various treatments on patients. For instance, cancer may be treated with radiation and chemotherapy; the latter in many treatment protocols requiring the implantation of an intravascular catheter during a prolonged period of time. To maximize the effect of such measures, as well as issues related to the patient Health Related Quality of Life (HRQoL), integrated and validated methodologies are needed as decisional basis for appropriate risk management and patient safety with regard to clinical use of intravascular catheters.The ambition of the REMISS project is to: Establish integrated and validated methodologies for risk management of the clinical use of intravascular catheters with respect to the clinical service lifetime, improved patient treatment, safety and HRQoL. This is assumed to reduce patient suffering due to complications associated with material deployment and degradation associated side effects for e.g. cancer patients receiving treatment with chemotherapeutical drugs using an intravascular catheter.The main vision is to improve the standards for eliminating side effects (complications) caused by deployment from and degradation of intravascular catheters, as well as loss of performance due to material-drug-biological system interactions, compared to the current state-of-the-art. Realising the project goals the rate of catheter-associated complications can be lowered by 40-50%, which in turn will improve patient treatment, safety and HRQoL, as well as health care related costs.Package integrally developed methodologies, predictive models, databases, and other project findings, as a potential product with a holistic coverage. It is believed that commercialisation of (selected) results will be the best option in order to create sustainable availability of this service based on continued research on intravascular catheters according to integrated and validated methodologies.REMISS answer the call NMBP-12-2017 Development of a Reliable Methodology for Better Risk Management of Engineered Biomaterials Advanced Therapy Medicinal Products and/or Medical Devices Marcy, P. Central venous access: techniques and indications in oncology. European Society of Radiology, 2008; 18; 2333-44 Maki DG, et al The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc 2006: 81 (9): 1159-71. Frostell, C., Björling, G., Strömberg, E., Karlsson, S., and Aune, R. E., Tracheal Implants Revisited, The Lancet (2017), 389(10075) pp.1191
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| 23. |
- Björling, Gunilla, Docent, et al.
(författare)
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Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating : a randomized clinical evaluation study
- 2015
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Ingår i: BMC Anesthesiology. - : BioMed Central. - 1471-2253 .- 1471-2253. ; 15, s. 1-10
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundHospital acquired infections worsen the outcome of patients treated in intensive care units and are costly. Coatings with silver or metal alloys may reduce or alter the formation of biofilm on invasive medical devices. An endotracheal tube (ETT) is used to connect the patient to a ventilator and coated tubes have been tested in relation to bacterial colonization and respiratory infection. In the present study, we aimed to evaluate and compare a coated and uncoated ETT for patient symptoms and local tracheal tolerability during short term clinical use. Degree of bacterial colonization was also described.MethodsA silver-palladium-gold alloy coating (‘Bactiguard®’Infection Protection, BIP) has been extensively used on urinary tract catheters and lately also on central venous catheters. We performed a randomised, single-blinded, controlled, first in man, post Conformité Européenne (EC) certification and CE marking study, focused on Bactiguard® coated ETTs (BIP ETT). Thirty patients at a tertiary university hospital scheduled for upper abdominal elective surgery with an expected duration of anaesthesia of at least 3 h were randomised; BIP ETT (n = 20) or standard ETT (n = 10). The tolerability was assessed with a modified version of Quality of Life Head and Neck Module, QLQ-H&N35 and by inspection of the tracheal mucosa with a fibre-optic bronchoscope before intubation and at extubation. Adverse Events (AE) and bacterial adherence were also studied. Statistical evaluations were carried out with the Fisher’s Exact Test, the Clopper-Pearson method, as well as a Proportional Odds Model.ResultsDifferences between groups were identified in 2 of 8 patient related symptoms with regard to tolerability by QLQ-H&N35 (cough, p = 0.022 and dry mouth, p = 0.014 in the treatment group.). No mucosal damage was identified with bronchoscopy. A low level of bacterial colonization with normal flora, equal between groups, was seen after short-term of intubation (median 5 h). No serious Adverse Events related to the use of an ETT were observed. The results should be treated with caution due to statistical confounders, a small study size and large inter-individual variability in bacterial adhesion.ConclusionsThe new device BIP ETT is well tolerated and has good clinical performance during short-term intubation. Studies with larger sample sizes and longer intubation periods (>24 h) in the ICU-setting are needed and can now be planned in order to identify possible differences in clinical outcomes.
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- Björling, Gunilla, Docent, et al.
(författare)
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Tracheostomy inner cannula care : a randomized crossover study of two decontamination procedures
- 2007
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Ingår i: American Journal of Infection Control. - : Elsevier BV. - 0196-6553 .- 1527-3296. ; 35:9, s. 600-5
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Today several methods for decontaminating inner cannulae exist. These methods are not based on scientific data, but often on local clinical tradition. This study compares two different decontamination methods. The aim was to find a practical and safe decontamination method. It is a randomized, single-blinded, comparative crossover study. METHODS: Fifty outpatients with long-term tracheostomy with an inner cannula were consecutively included and randomly allocated to begin with one of two different treatment sequences: detergent and chlorhexidine-alcohol (A) or detergent (B). Samples for bacterial culture were taken before and after decontamination, and the number of bacteria colonies was counted. RESULTS: Before decontamination, the inner cannulae grew high numbers of bacteria, which were parts of the normal flora of the upper respiratory tract and did not differ significantly between the two sequences (AB; BA). The primary variable was the culture count value after chlorhexidine-alcohol/detergent (A) and detergent (B). The effects of both methods were larger than expected, and the results showed a nearly total elimination of organisms. The equivalence criterion, ratio of mean colony counts (A/B) >0.8, was met at a significance level of P<0.001. CONCLUSIONS: Cleaning the tracheostomy inner cannula with detergent and water is sufficient to achieve decontamination.
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