Dataset Information

The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial.

ABSTRACT:

Background

Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remains open. National surveys in some European countries showed that the use of FB is non-standardized. Retrospective studies have not shown a significant difference in complications between procedures performed with or without a bronchoscope. International guidelines have not been able to establish recommendations regarding the use of FB in PDT due to lack of evidence.

Design

This is a multicenter (three centers at the time of publishing this paper) randomized controlled clinical trial to examine the safety of percutaneous tracheostomy using FB. We will include all consecutive adult patients admitted to the ICU in whom percutaneous tracheostomy for prolonged mechanical ventilation is indicated and with no exclusion criteria for using FB. Eligible patients will be randomly assigned to receive blind PDT or PDT under endoscopic guidance. All procedures will be performed by experienced intensivists in PDT and FB. A Data Safety and Monitoring Board (DSMB) will monitor the trial. The primary outcome is the incidence of perioperative complications.

Discussion

FB is a safe technique when performing PDT although its use is not universally accepted in all ICUs as a routine practice. Should PDT be monitored routinely with endoscopic guidance? This study will assess the role of FB monitoring during PDT.

Trial registration

ClinicalTrials.gov NCT04265625. Registered on February 11, 2020.

SUBMITTER: Anon JM

PROVIDER: S-EPMC8240418 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundApart from conventional reusable bronchoscopes, single-use bronchoscopes (SUB) were recently introduced. Data suggest that SUB might prevent from the risk of cross contamination (i.e. multiresistant pathogens, SARS CoV-2) and save costs. We aimed to investigate visualization, ventilation, handling characteristics, changes in patients' gas exchange, and costs associated with both types of bronchoscopes during percutaneous dilatational tracheostomy (PDT).MethodsIn this prospective, randomized, noninferiority study, 46 patients undergoing PDT were randomized 1:1 to PDT with SUB (Ambu aScope) or reusable bronchoscopes (CONV, Olympus BF-P60). Visualization of tracheal structures rated on 4-point Likert scales was the primary end-point. Furthermore, quality of ventilation, device handling characteristics, changes in the patients' gas exchange, pH values, and costs were assessed.ResultsNoninferiority for visualization (the primary endpoint) was demonstrated for the SUB group. Mean visualization scores (lower values better) were 4.1 (95% confidence intervals: 3.9;4.3) for SUB vs. 4.1 (4.0;4.2) for CONV. Noninferiority of ventilation (estimated by minute volume and SpO2) during the procedure could be shown as well. Mean score was 2.6 (2.0;3.1) for SUB vs. 2.4 (2.1;2.7) for CONV (lower values better). No significant differences regarding handling (SUB: 1.2 (1.0;1.4), CONV: 1.3 (1.1;1.6)), blood gas analyses and respiratory variables were found. Cost analysis in our institution revealed 93 € per conventional bronchoscopy versus 232.50 € with SUB, not considering an estimate for possible infection due to cross-contamination with the reusable device.ConclusionIn our study, visualization and overall performance of the SUB during PDT were noninferior to reusable bronchoscopes. Therefore, PDT with SUB is feasible and should be considered if favored by individual institution's cost analysis.Trial registrationClinicalTrials.gov, NCT03952247 . Submitted for registration on 28/04/2019 and first posted on 16/05/2019.

Project description:INTRODUCTION: Tracheostomy is one of the more commonly performed procedures in critically ill patients yet the optimal method of performing tracheostomies in this population remains to be established. The aim of this study was to systematically review and quantitatively synthesize all randomized clinical trials (RCTs), comparing elective percutaneous dilatational tracheostomy (PDT) and surgical tracheostomy (ST) in adult critically ill patients with regards to major short and long term outcomes. METHODS: MEDLINE, EMBASE, CINAHL and the Cochrane Controlled Clinical Trials Register databases were searched to identify relevant studies. Additionally, bibliographies and selected conference proceedings were reviewed, and experts in the field and manufacturers of two PDT kits were contacted. Randomized clinical trials comparing any method of elective PDT to ST that included critically ill adults and reported at least one clinically relevant outcome were included. Data extracted included trial characteristics, measures of study validity, and clinically relevant outcomes. RESULTS: Seventeen RCTs involving 1,212 patients were included. Most PDTs used a multiple dilator technique and were performed in the intensive care unit (ICU). The pooled odds ratio (OR) for wound infection was 0.28 (95% confidence interval (CI), 0.16 to 0.49, p < 0.0005), indicating a significant reduction with PDT compared to ST. Overall, PDT was equivalent to ST for bleeding, major peri-procedural and long-term complications; however, subgroup analysis suggested PDT resulted in a lower incidence of bleeding (OR = 0.29 (95% CI 0.12 to 0.75, p = 0.01)) and death (OR = 0.71 (95% CI 0.50 to 1.0, p = 0.05)) when the STs were performed in the operating theatre. CONCLUSION: PDT reduces the overall incidence of wound infection and may further reduce clinical relevant bleeding and mortality when compared with ST performed in the operating theatre. PDT, performed in the ICU, should be considered the procedure of choice for performing elective tracheostomies in critically ill adult patients.

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