Evaluation of the Novel Antimicrobial BCP3 in a Coating for Endotracheal Tubes.
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SUBMITTER: Ozcelik B
PROVIDER: S-EPMC7226855 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
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Evaluation of the Novel Antimicrobial BCP3 in a Coating for Endotracheal Tubes.
Ozcelik Berkay B Pasic Paul P Sangwan Parveen P Be Cheang Ly CL Glattauer Veronica V Thissen Helmut H Boulos Ramiz A RA
ACS omega 20200428 18
Ventilator-associated pneumonia (VAP) is a highly common hospital-acquired infection affecting people that require mechanical ventilation. The endotracheal tube (ETT) used during the ventilation process provides a surface that can allow bacterial colonization and biofilm formation, which can lead to VAP. Although various approaches, including ETT design and material selection, as well as antimicrobial coatings have been employed to minimize adverse events, VAP remains a significant unresolved cl ...[more]
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Project description:Hospital 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.A 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.Differences 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.The 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.Registered in ClinicalTrials.gov,NCT01682486 , Date of Registration: August, 30, 2012.
| S-EPMC4667467 | biostudies-literature
Project description:Corticosteroid-eluting endotracheal tubes (ETTs) were developed and employed in a swine laryngotracheal injury model to maintain airway patency and provide localized drug delivery to inhibit fibrotic scarring. Polycaprolactone (PCL) fibers with or without dexamethasone were electrospun onto the ETT surface PCL-only coated ETTs and placed in native airways of 18 Yorkshire swine. Regular and dexamethasone-PCL coated ETTs were placed in airways of another 18 swine injured by inner laryngeal mucosal abrasion. All groups were evaluated after 3, 7 and 14 days (n = 3/treatment/time). Larynges were bisected and localized stiffness determined by normal indentation, then sequentially matched with histological assessment. In the native airway, tissue stiffness with PCL-only ETT placement increased significantly from 3 to 7 days (p = 0.0016) and 3 to 14 days (p < 0.0001) while dexamethasone-PCL ETT placement resulted in stiffness decreasing from 7 to 14 days (p = 0.031). In the injured airway, localized stiffness at 14 days was significantly greater after regular ETT placement (23.1 ± 0.725 N/m) versus dexamethasone-PCL ETTs (17.10 ± 0.930 N/m, p < 0.0001). Dexamethasone-loaded ETTs were found to reduce laryngotracheal tissue stiffening after simulated intubation injury compared to regular ETTs, supported by a trend of reduced collagen in the basement membrane in injured swine over time. Findings suggest localized corticosteroid delivery allows for tissue stiffness control and potential use as an approach for prevention and treatment of scarring caused by intubation injury.
| S-EPMC10837152 | biostudies-literature
Project description:BackgroundVentilator-associated pneumonia (VAP) causes increased mortality, prolonged hospital stay and increased healthcare costs. Prevention of VAP in intensive care units (ICUs) is currently based on several measures, and application of noble metal coating on medical devices has been shown to inhibit the bacterial adherence of microorganisms to the surface. The objective of this study was to evaluate the potential benefit of noble metal coating of endotracheal tubes for the prevention of VAP.MethodsThis was a multi-center, randomized, controlled, double-blind, prospective study including ventilated patients from nine ICUs from four hospital sites in Belgium. Patients were randomly intubated with identical appearing noble metal alloy (NMA) coated (NMA-coated group) or non-coated (control group) endotracheal tubes (ETT). Primary endpoint was the incidence of VAP. Secondary endpoints were the proportion of antibiotic days during ICU stay and tracheal colonization by pathogenic bacteria.ResultsIn total, 323 patients were enrolled, 168 in the NMA-coated group and 155 in the control group. During ventilation, VAP occurred in 11 patients (6.5%) in the NMA-coated group and in 18 patients (11.6%) in the control group (p = 0.11). A higher delay in VAP occurrence was observed in the NMA-coated group compared with the control group by Cox proportional hazards regression analysis (HR 0.41, 95% CI 0.19-0.88, p = 0.02). The number of antibiotic days was 58.8% of the 1,928 ICU days in the NMA-coated group and 65.4% of the 1774 ICU days in the control group (p = 0.06). Regarding tracheal colonization, bacteria occurred in 38 of 126 patients in the NMA-coated group (30.2%) and in 37 of 109 patients in the control group (33.9%) (p = 0.57).ConclusionsThis study provides preliminary evidence to support the benefit of noble metal coating in the prevention of VAP. A confirmatory study in a larger population would be valuable.Trial registrationClinical trial number: NCT04242706 ( http://www.clinicaltrials.gov ).
| S-EPMC8723906 | biostudies-literature
Project description:BackgroundSecretions accumulate in endotracheal tubes' (ETT) lumens upon their placement in patients. The secretions impact airway resistance and pressure. Secretions potentiate prolonged mechanical ventilation and ventilator-associated pneumonia. Our primary objective in this study was to evaluate an ETT-clearing device (ETT-CD) in its ability to remove secretions from ex vivo ETT lumens.MethodsForty ETTs, obtained from intensive care patients at extubation, were individually placed into a ventilator field performance testing simulator at 37°C. The pressure drop through the ETTs was measured at a flow rate of 60?L/min before and after cleaning with the ETT-CD and compared with unused, similarly sized controls tubes. The ETT-CD was inserted into an ETT until the tip reached Murphy's eye (hole in the side) of the ETT. The wiper, set back from the tip, was expanded by ETT-CD handle activation. As the ETT-CD was removed, the distal wiper extracted secretions from the ETT lumen.ResultsForty ETTs were tested with nonparametric Wilcoxon signed-rank tests. Before being cleared with the ETT-CD, the median pressure drop in the extubated 7.5?mm ETTs was 17.8?cm H2O; after ETT-CD use, it was 12.3. The cleared ETTs were significantly improved over the ETTs before being cleared (p < 0.001); however, there remained a significant difference between the cleared ETTs and the control tubes (p=0.005), indicating the clearing was not to the level of an unused ETT. Similar results were determined for the 8.0?mm ETTs.ConclusionsFor the 7.5?mm and the 8.0?mm EETs, the ETT-CD improved effective patency of the ETTs over the uncleared ETTs, independent of occlusion location, tube size, or length of tube. However, there remained a significant difference between the cleared tubes and controls.
| S-EPMC6311789 | biostudies-literature
Project description:BackgroundThe importance of environmental contamination in the transmission of pathogens among hospitalized patients is universally recognized, and disinfection of surfaces is a widely accepted modality for reducing healthcare-associated infections. Nevertheless, hospital disinfection is still suboptimal. In this study, we evaluated the sustained effects of the novel formulation OxiLast™ which extends the antimicrobial effects of chlorine-based disinfectants.MethodsIn an experimental lab phase, PVC surfaces were coated with OxiLast™ and then inoculated with representative Gram-positive and Gram-negative pathogenic bacteria. Cells were recovered at different contact times (5, 15, 30 min) to assess the reduction in bacterial counts compared to uncoated surfaces and also subject to various challenges to assess robustness. A similar methodology was then applied in an unoccupied hospital room to evaluate the sustained effect of OxiLast™ on high-touch surfaces.ResultsOxiLast™ demonstrated notable activity against the range of bacterial strains tested with ≥ 4 log10 reduction in bacterial counts observed for up to seven days following one surface application, for various strains and contact times. Similar results were observed following challenges such as simulated abrasion of coated surfaces, organic contamination or successive inoculations. The results were confirmed in a simulated patient care environment.ConclusionsThe addition of OxiLast™ to common chlorine-based disinfectants has shown a substantial and sustained reduction in bacterial pathogen counts for up to 7 days following one application. The consistent results in the laboratory and hospital are promising and should be tested in a real-life clinical scenario.
| S-EPMC10666328 | biostudies-literature
Project description:BackgroundBiofilm formation on endotracheal tubes (ETTs) is an early and frequent event in mechanically ventilated patients. The biofilm is believed to act as a reservoir for infecting microorganisms and thereby contribute to development and relapses of ventilator-associated pneumonia (VAP). Once a biofilm has formed on an ETT surface, it is difficult to eradicate. This clinical study aimed to compare biofilm formation on three widely used ETTs with different surface properties and to explore factors potentially predictive of biofilm formation.MethodsWe compared the grade of biofilm formation on ETTs made of uncoated polyvinyl chloride (PVC), silicone-coated PVC, and PVC coated with noble metals after > 24 h of mechanical ventilation in critically ill patients. The comparison was based on scanning electron microscopy of ETT surfaces, biofilm grading, surveillance and biofilm cultures, and occurrence of VAP.ResultsHigh-grade (score ≥ 7) biofilm formation on the ETTs was associated with development of VAP (OR 4.17 [95% CI 1.14-15.3], p = 0.031). Compared to uncoated PVC ETTs, the silicone-coated and noble-metal-coated PVC ETTs were independently associated with reduced high-grade biofilm formation (OR 0.18 [95% CI 0.06-0.59], p = 0.005, and OR 0.34 [95% CI 0.13-0.93], p = 0.036, respectively). No significant difference was observed between silicon-coated ETTs and noble-metal-coated ETTs (OR 0.54 [95% CI 0.17-1.65], p = 0.278). In 60% of the oropharyngeal cultures and 58% of the endotracheal cultures collected at intubation, the same microorganism was found in the ETT biofilm at extubation. In patients who developed VAP, the causative microbe remained in the biofilm in 56% of cases, despite appropriate antibiotic therapy. High-grade biofilm formation on ETTs was not predicted by either colonization with common VAP pathogens in surveillance cultures or duration of invasive ventilation.ConclusionHigh-grade biofilm formation on ETTs was associated with development of VAP. Compared to the uncoated PVC ETTs, the silicone-coated and noble-metal-coated PVC ETTs were independently associated with reduced high-grade biofilm formation. Further research on methods to prevent, monitor, and manage biofilm occurrence is needed.Trial registrationClinicalTrials.gov NCT02284438 . Retrospectively registered on 21 October 2014.
| S-EPMC7322705 | biostudies-literature
Project description:BackgroundBiofilm on the surface of endotracheal tubes (ETTs) is associated with ventilator-associated pneumonia. The use of silver-coated ETTs has been suggested to reduce the occurrence of ventilator-associated pneumonia by preventing biofilm formation. However, mucus accumulation can reduce the antibacterial activity of silver-coated ETTs by isolating bacterial colonies from the silver surface. We hypothesized that, in mechanically ventilated subjects, periodic removal of secretions through the use of a cleaning device would enhance the antimicrobial properties of silver-coated ETTs and thus reduce bacterial colonization.MethodsSubjects were randomized to either standard suctioning (blind tracheal suctioning, control group) or blind tracheal suctioning plus cleaning maneuver every 8 h (treatment group). Tracheal aspirates were collected immediately before extubation for microbiological culture. After extubation, ETTs were collected for both cultural and non-cultural microbiological analysis and biofilm isolation.Results39 subjects expected to be ventilated for > 48 h were enrolled; 36 ETTs (18 control, 18 treatment) and 29 tracheal samples (15 control, 14 treatment) were collected. Among the ETTs positive for bacterial colonization (15 vs 9, P = .18), cleaning maneuvers did not reduce microbial load, shown as the decimal logarithm of colony-forming units (CFU) per mL (1.6 ± 1.2 vs 0.9 ± 1.2 logCFU/mL, P = .15). There was a trend toward decreased biofilm deposition (439.5 ± 29.0 vs 288.9 ± 157.7 mg, P = .09) in the treated ETTs. No significant differences were observed in the number of positive tracheal aspirates (13 vs 10, P = .39) or in the microbial load (4.8 ± 4.0 vs 4.2 ± 3.8 logCFU/mL, P = .70) of tracheal secretions. Finally, no differences in the microbial load of Gram-positive organisms, Gram-negative organisms, or yeasts were found between the ETTs and tracheal aspirates of the 2 groups.ConclusionsIn 39 critically-ill subjects intubated with silver-coated ETTs, periodic cleaning maneuvers did not decrease bacterial colonization of the ETTs and did not lower respiratory tract colonization compared to the standard suctioning. (Clinicaltrials.gov registration NCT02120001.).
| S-EPMC10068633 | biostudies-literature
Project description:Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns.We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial.This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP.A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n?=?77), and the remainder occurred out of hospital (n?=?25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices.A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).
| S-EPMC4722846 | biostudies-literature
Project description:BackgroundRecommendations for endotracheal tube (ETT) size usually refer to the inner diameter (ID). Outer diameters (OD), however, vary greatly between manufacturers, which in some brands might cause difficulties in passing the ETT through the nostrils if choosing the nasal route for intubation. Even though the nostrils are dilatable by an ETT, it might be difficult to pass an ETT through the posterior naris (narrowest point of the nasal passage), if the OD is bigger than the nostrils. Therefore, nostril size may provide some guidance for the appropriate ETT size preventing unsuccessful intubation attempts. This study therefore compares nostril sizes of newborn infants with ODs of ETTs from several manufacturers.MethodsThis is a subgroup analysis of a prospective observational study, performed in a single tertiary perinatal centre in Germany. The diameter of the nostril of infants born between 34 and 41 weeks´ gestation was measured in 3D images using 3dMDvultus software and compared to the OD of ETT from five different manufacturers.ResultsComparisons of nostril sizes with ODs of different ETTs were made for 99 infants with a mean (SD) birthweight of 3058g (559) [range: 1850-4100g]. Mean (SD) nostril size was 5.3mm (0.6). The OD of the 3.5mm ETT of different manufacturers ranged from 4.8-5.3mm and was thus larger than the nostril size of 20-46% of late preterm or term infants. Some OD of a 3.0mm ETT were even bigger than the OD of a 3.5mm ETT (e.g. the 3.0mm ETT from Rüsch® has an OD of 5.0mm while the 3.5mm ETT from Portex® has an OD of 4.8mm).ConclusionsClinicians should be aware of the OD of ETTs to reduce unsuccessful intubation attempts caused by ETT sizes not fitting the nasal cavity. Generated data may help to adapt recommendations in future.Trial registrationSubgroup analysis of the "Fitting of Commonly Available Face Masks for Late Preterm and Term Infants (CAFF)"-study: NCT03369028, www.ClinicalTrials.gov , December 11, 2017.
| S-EPMC8459504 | biostudies-literature
Project description:ObjectivesTo evaluate the expression dynamics of biofilm genes in methicillin-resistant Staphylococcus aureus (MRSA) retrieved from endotracheal tubes (ETT) and to determine how gene regulation is attenuated in vitro where host-environmental factors are no longer present.MethodsBiofilm was grown (24 h) in tryptic broth soy plus 0.25% glucose for a clinical MRSA isolate in planktonic state and after sessile growth named ETT-MRSA (S2, S3, S4, S5, S6, S7). Gene expression of five biofilm-related genes (icaC, clfB, ebps, fnbB, and RNA III) was assessed consecutively from day 1 to day 4 after ETT growth through real-time PCR. 16S rRNA was used as a control.ResultsThe MRSA isolates retrieved from ETT were capable of producing biofilms dependent on ica. The gene expression dynamics of ETT-MRSA changed progressively compared to planktonic MRSA gene expression under both ambient air (p < 0.001) and ambient air with 5% CO2 (p < 0.001). Dynamic assessment of icaC expression in both atmospheric conditions showed progressive downregulation in vitro compared to in vivo ETT biofilms. The expression patterns of clfB and ebps genes were similar to icaC. In contrast, the expression of the RNA III gene showed progressive upregulation from day 1 to day 4 (p < 0.001).ConclusionsMRSA loses its biofilm gene expression in vitro, by adaptive features across multiple generations, as evidenced by the progressive downregulation of icaC and upregulation of RNA III. These findings underscore the significance of host-environment dependence in regulating bacterial biofilm genes, highlighting its importance in diagnostics. Bacterial strains lose their host-specific characteristics as they are cultured in vitro.
| S-EPMC10892081 | biostudies-literature