Bronchial Stents
Conditions
Keywords
Airway, Stent, Bronchoscopy, Surveillance
Brief summary
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Interventions
DEVICEBronchoscopy
Bronchoscopy is a procedure that uses a bronchoscope (a thin, tube-like instrument with a light and a lens for viewing) to examine the inside of the trachea, bronchi (air passages that lead to the lungs), and lungs. The bronchoscope is inserted through the nose or mouth.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.
Exclusion criteria
* Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment. * Lobar or segmental stents alone * Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy * Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks) * Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of stent-related complications warranting an intervention | 3 months after enrollment | Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalizations due to stent-related complications | 3 months after enrollment | Number of hospitalizations due to stent-related complications |
| Number of unscheduled visits due to stent-related complications | 3 months after enrollment | Number of unscheduled visits due to stent-related complications |
| Number of urgent care or emergency room visits due to stent-related complications | 3 months after enrollment | Number of urgent care or emergency room visits due to stent-related complications |
| Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging | 3 months after enrollment | Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging |
| Protocol Feasibility Composite Score | 3 months after enrollment | A composite score comprised from recruitment success (enrollment of target participant numbers), protocol adherence, data completeness, intervention safety, and resource availability to measure protocol feasibility. The total scale for the composite score is 1 to 5, with higher score indicating more feasibility. |
Countries
United States
Contacts
Primary ContactAxel Duval, MD
Outcome results
None listed