Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Study Overview
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Brief Summary
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Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations to prevent transmission of infectious agents from patient to patient. These operations have a significant material and human cost and impact their availability in case of emergency. One alternative is the use of disposable FB. The aim of the study is to evaluate the quality of FB during procedures carried out with each of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia (A) department. A prospective non-interventional and non-randomized monocentric study compare the operator satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4® (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image and suction quality.

Official Title
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Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Conditions
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Bronchoscope Users

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent a therapeutic bronchoscopy (Bronchoalveolar lavage, protected bronchial brushing, suction, difficult intubation) Patient followed or treated at the Limoges University Hospital Exclusion Criteria: Patient < 18 years Diagnostic bronchoscopy Interventional bronchoscopy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchial endoscopy<br>Compare quality procedures performed with reusable versus disposable bronchoscopes in respiratory endoscopy unit | |
| Critical care unit<br>Compare quality procedures performed with reusable versus disposable bronchoscopes in critical care unit | |
| Anesthesia department<br>Compare quality procedures performed with reusable versus disposable bronchoscopes in anesthesia department | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | Time required to carry out the bronchoscopy (between 5 and 15 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passage of the endoscope through the probe (intubated patient): comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Bronchoscope access to trachea (non-intubated patient): comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Bronchial catheterization: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: very difficult 4/10: difficult 6/10: relatively easy 8/10: easy 10/10: very easy | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Left/right rotation of the insertion tube: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Crutch handling: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Close brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Outer brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Close focus: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Close sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Outer sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Color reproduction: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Image contrast: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Image size: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Reproduction of anatomic reality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 
| Suction quality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB | A score is given per bronchoscopy (RU FB or disposable FB) All scores are aggregated as an average for FB RU and as an average for disposable FBs The 2 averages obtained are compared by a Student T- test after verification of the application conditions by a Fisher F-test (alpha = 5% threshold) Additional information about the measurement: 2/10: poor 4/10: mediocre 6/10: sufficient 8/10: suitable 10/10: excellent | time required to carry out the bronchoscopy (between 5 and 15 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection