Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

• Conditions: Bronchoscope Users

• Registration Number: NCT03392610
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-12-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	Time required to carry out the bronchoscopy (between 5 and 15 minutes)	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

Secondary Outcome Measures

Name	Time	Method
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	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
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	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Bronchial catheterization: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
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	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Crutch handling: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Close brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Outer brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Close focus: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Close sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Outer sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Color reproduction: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Image contrast: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Image size: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Reproduction of anatomic reality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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
Suction quality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB	time required to carry out the bronchoscopy (between 5 and 15 minutes)	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

Trial Locations

Locations (1)

University hospital, Limoges; 🇫🇷 Limoges, France