Bronchoscopic Interventions
Conditions
Brief summary
The goal of this pilot single-arm crossover trial is to investigate the feasibility and safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic interventional pulmonary procedures instead of reusable flexible bronchoscopes (RFB). The main questions it aims to answer are: Was a decision to crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) made ? Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including: 1. Overall assessment 2. Scope quality 3. Scope handling 4. Scope maneuverability 5. Tool compatibility 6. Suction 7. Lavage 8. Safety 9. Image quality Participants will undergo bronchoscopy with single use bronchoscopes.
Interventions
DEVICESingle use bronchoscope
Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.
Sponsors
Beth Israel Deaconess Medical Center
Olympus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Able to provide informed consent.
Exclusion criteria
1. Emergent procedure 2. Pregnancy 3. Study subjects have any diseases or conditions that interferes with safe completion of the biopsy including: cardiopulmonary instability; sensitivity to drugs that could be administered during bronchoscopy; active anticoagulation or antiplatelet therapy (warfarin, direct Xa inhibitors, thrombin inhibitors, low molecular weight heparin, unfractioned heparin, clopidogrel) not held adequately prior to the procedure; uncontrolled blood dyscrasias; concurrent pneumothorax or bullae.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) | During the procedure |
Countries
United States
Contacts
CONTACTChristine Conley
Outcome results
None listed