Single Use Bronchoscopes for Interventional Pulmonology
Status
Conditions
Treatments
Details and patient eligibility
About
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:
- Overall assessment
- Scope quality
- Scope handling
- Scope maneuverability
- Tool compatibility
- Suction
- Lavage
- Safety
- Image quality
Participants will undergo bronchoscopy with single use bronchoscopes.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age 18 or older
- Able to provide informed consent.
Exclusion criteria
- Emergent procedure
- Pregnancy
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Christine Conley
Data sourced from clinicaltrials.gov
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