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Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

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ClinicalTrials.gov Identifier: NCT03222869
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment
Laryngotracheal Stenosis 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.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

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




Primary Outcome Measures :
  1. Pressure (cm H20) [ Time Frame: Up to One Year ]
    Using a pressure gauge to measure pressure at locations in the airway


Secondary Outcome Measures :
  1. Flow Rate (L/min) [ Time Frame: Up to One Year ]
    using a flow sensor to measure low rate at locations in airway



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that require outpatient endoscopic laryngeal airway surgery in the operating room.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222869


Contacts
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Contact: Alexander Hillel, MD 410-955-1654 ahillel@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Alexander Hillel, MD    410-955-1654    ahillel@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Alexander Hillel, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03222869    
Other Study ID Numbers: IRB00096150
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No