Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

Completed

• Conditions: Laryngotracheal Stenosis
• Interventions: Diagnostic Test: Measure Airway Resistance Across Stenosis

• Registration Number: NCT03222869
• Lead Sponsor: Johns Hopkins University

Brief Summary

This research is being done to determine the resistance across stenosis in the airway.

Detailed Description

There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.

Study Timeline

• Study Start: 2017-03-29
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.

Exclusion Criteria

• Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)
• Patients that are not cleared for surgery by the preoperative evaluation
• Patients with severe laryngotracheal stenosis
• Patients who are morbidly obese (BMI > 40)
• Patients with lung disease (asthma, COPD)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laryngotracheal Stenosis	Measure Airway Resistance Across Stenosis	Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured

Primary Outcome Measures

Name	Time	Method
Pressure (cm H20)	Up to One Year	Using a pressure gauge to measure pressure at locations in the airway

Secondary Outcome Measures

Name	Time	Method
Flow Rate (L/min)	Up to One Year	using a flow sensor to measure low rate at locations in airway

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States