Viewing Study NCT03222869


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Study NCT ID: NCT03222869
Status: COMPLETED
Last Update Posted: 2023-10-13
First Post: 2017-07-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Sponsor: Johns Hopkins University
Organization:

Study Overview

Official Title: Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery
Status: COMPLETED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: