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Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03392610
Enrollment
500
Registered
2018-01-08
Start date
2017-10-01
Completion date
2019-06-30
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscope Users

Keywords

Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection

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.

Interventions

None listed

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FBTime 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

MeasureTime frameDescription
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 FBtime 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 disposabletime 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 FBtime 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 FBtime 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 FBtime 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 FBtime 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 FBtime 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
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 FBtime 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
Outer sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FBtime 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 FBtime 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 FBtime 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 FBtime 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 FBtime 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 FBtime 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 disposabletime 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

Countries

France

Contacts

Primary ContactValentin David
valentin.david@chu-limoges.fr+33618500489
Backup ContactThomas DAIX
thomas.daix@chu-limoges.fr+33555054082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026