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OpenTrials
Completed

NCT Number: NCT03222869

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Measure Airway Resistance Across Stenosis

Diagnostic Test

Measure pressure and air flow Across Stenosis

Primary outcomes

  1. Pressure (cm H20)

    Time frame: Up to One Year

    Using a pressure gauge to measure pressure at locations in the airway

Secondary outcomes

  1. Flow Rate (L/min)

    Time frame: Up to One Year

    using a flow sensor to measure low rate at locations in airway

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2017
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.