Clinical trial NCT03392610: Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey
Official title: Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchoscope Users
Keywords: Intratracheal intubation, bronchoscopy, bronchoalveolar lavage, endoscopy, pulmonary medicine, critical care, anesthesia department, disinfection
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent therapeutic bronchoscopy in anesthesia department, respiratory endoscopy unit, and critical care unit

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bronchoscopes overall reliability: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: Time required to carry out the bronchoscopy (between 5 and 15 minutes)
Secondary outcomes:
measure: 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
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: 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
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Bronchial catheterization: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: 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
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Crutch handling: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Close brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Outer brightness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Close focus: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Close sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Outer sharpness: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Color reproduction: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Image contrast: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Image size: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Reproduction of anatomic reality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
measure: Suction quality: comparison of physician satisfaction scores (rated on a scale from 0 to 10) between RU FB and disposable FB
timeFrame: time required to carry out the bronchoscopy (between 5 and 15 minutes)
Other outcomes:
Locations:
city: Limoges
country: France
facility: University hospital, Limoges
Study officials:
References: