Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

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

Study Overview

• Status: Completed
• Conditions: Laryngotracheal Stenosis
• Intervention / Treatment: Diagnostic test: Measure Airway Resistance Across Stenosis

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laryngotracheal Stenosis; Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured	Diagnostic test: Measure Airway Resistance Across Stenosis; Measure pressure and air flow Across Stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure (cm H20)	Using a pressure gauge to measure pressure at locations in the airway	Up to One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Rate (L/min)	using a flow sensor to measure low rate at locations in airway	Up to One Year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Alexander Hillel, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB00096150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No