Stenosis of Trachea
Conditions
Keywords
Stenosis of trachea, benign, spray cryotherapy
Brief summary
The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\[s\] investigators aim to answer are: 1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone? 2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone. Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention. Participants will surgery and receive one of the two interventions.
Detailed description
Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients. Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.
Interventions
PROCEDURESpray cryo therapy
normal flow, 5 seconds repeated for 3-5 cycles
PROCEDUREStandard of Care (SOC)
1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter)
Sponsors
American Association of Broncology and Interventional Pulmonology
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space. * 2\. Stenotic airway of diameter \< 1cm.
Exclusion criteria
1. Complex stenosis, cartilage involvement (malacia or fracture). 2. Patients with giant bullae (\> a third of hemithorax) or bullae \>3cm. 3. Concurrent tracheoesophageal fistula, active tracheal malignancy. 4. Presence of concomitant upper airway obstruction. 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need of re intervention | Need of re intervention in two years | Number of patients that require new intervention for the benign airway stenosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to re intervention | Two years | Time it takes in days for a patient to need a re intervention for the benign airway stenosis after treatment. |
Countries
United States
Contacts
Primary ContactChristine Conley
Outcome results
None listed