Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

NCT ID: NCT03222869

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-29

Study Completion Date

2022-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Laryngotracheal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laryngotracheal Stenosis

Patients with laryngotracheal stenosis will have pressure sensors placed proximal and distal to the stenosis. Pressure and air flow will be measured

Measure Airway Resistance Across Stenosis

Intervention Type DIAGNOSTIC_TEST

Measure pressure and air flow Across Stenosis

Interventions

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Measure Airway Resistance Across Stenosis

Measure pressure and air flow Across Stenosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Hillel, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00096150

Identifier Type: -

Identifier Source: org_study_id

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