Surveillance Versus Bronchoscopy After Airway Stenting

Icahn School of Medicine at Mount Sinai50 enrolled

Overview

Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bronchial Stents

Interventions

BronchoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The Mount Sinai Health System

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Number of stent-related complications warranting an intervention

Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention