| 1. |
- 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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| 2. |
- 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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| 3. |
- Björling, Gunilla, et al.
(författare)
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Evaluation of central venous catheters coated with a noble metal alloy - A randomized clinical pilot study of coating durability, performance and tolerability
- 2018
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Ingår i: Journal of Biomedical Materials Research. Part B - Applied biomaterials. - : John Wiley & Sons. - 1552-4973 .- 1552-4981. ; 106:6, s. 2337-2344
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Tidskriftsartikel (refereegranskat)abstract
- The use of Central Venous Catheters (CVCs) commonly results in complications. Coatings with silver or metal alloys can reduce the risk associated with the use of CVC. We have evaluated the durability of a noble metal coated CVC (the Bactiguard Infectious Protection, BIP CVC) and compared with an uncoated CVC for clinical tolerability (Adverse Events, AEs) and performance, in order to create a baseline for a large future study. Patients undergoing major surgery, randomised at a 2:1 ratio to BIP CVC (n = 22) or standard CVC (n = 12), were catheterized 9 - 12 days, respectively. Adverse events, microbial colonization and metal release were measured.FINDINGS: There were no AEs in the BIP CVC-group, but 5 AEs occurred in 4 patients (1 patient had 2 AEs) in the standard CVC-group, p = 0.011 (whereof 3 were catheter related). The BIP CVC showed an initial release of coating metals in blood (gold, silver and palladium), which rapidly decreased and were far below Permitted Paily Exposure (PDE) for chronical use. The levels of silver concentration were far below those needed to develop microbial resistance. The performance was equal, and there was no difference concerning microbial colonization, for the two CVCs.CONCLUSION: In this pilot study the BIP CVC had significantly lower AEs and showed a comparable performance to the standard CVC. The coating was durable throughout the study length (up to 16 days) and toxicological evaluation showed good safety margins. Larger studies are needed.
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| 4. |
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| 5. |
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| 6. |
- Björling, Gunilla, et al.
(författare)
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Long-Term Tracheostomy : Aspects on Tube Change and Material Wear
- 2007
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Konferensbidrag (refereegranskat)abstract
- The tracheostomy tubes in use are exposed not only to bacteria but also the lining fluids, which are a first defence against toxicity in inhaled gases. It contains several antioxidants. The complex bacteriological environment in the trachea, as well as the formation of a biofilm on the tube surface through colonization of bacteria, is believed to affect the mechanical and chemical properties of the tube material. The study was conducted at the National Respiratory Centre (NRC) at Danderyd Hospital in collaboration with the Royal Institute of Technology and Sophiahemmet University College in Stockholm, Sweden.
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| 7. |
- 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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| 8. |
- 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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| 9. |
- Castegren, Markus, 1976-
(författare)
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Modulating Organ Dysfunction in Experimental Septic Shock : Effects of Aminoglycosides, Antiendotoxin Measures and Endotoxin Tolerance
- 2011
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Sepsis is a common diagnose in the intensive care population, burdened with a high mortality. The systemic inflammatory reaction underlying the development of septic organ dysfunction can be modeled using Gram-negative bacterial lipopolysaccharide, endotoxin. This thesis used a porcine endotoxemic experimental sepsis model to address clinical questions difficult to answer in clinical trials; furthermore a model of secondary sepsis was developed. No additional effect on the development of renal dysfunction by tobramycin was found, indicating that a single dose of tobramycin does not further compromise renal function in inflammatory-induced acute kidney injury. Antiendotoxin treatment had no measurable effect on TNF-α-mediated toxicity once the inflammatory cascade was activated. There was an effect on the leukocyte response that was associated with improvements in respiratory function and microcirculation, making it impossible to rule out fully the beneficial effect of this strategy. However, the effects were limited in relation to the magnitude of the endotoxin concentration reduction and the very early application of the antiendotoxin measure. The lungs stood out compared to the other organ systems as having a threshold endotoxin dose for the protective effect of endotoxin tolerance. As to the development of circulatory and renal dysfunction, tolerance to endotoxin was evident regardless of the endotoxin pre-exposure and challenge dose. There was a temporal variation of endotoxin tolerance that did not follow changes in plasma TNF-α concentrations and maximal tolerance was seen very early in the course. More pronounced endotoxin tolerance at the time of maximum tolerance was associated with a more marked hyperdynamic circulation, reduced oxygen consumption and thrombocytopenia eighteen hours later. It might be of interest to use the experimental model of long-term endotoxemia followed by a second hit, which has been designed to resemble an intensive care setting, for the study of treatment effects of immunomodulating therapies in secondary sepsis.
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