Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 9:38 PM
Study NCT ID:
NCT04979533
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2021-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Insufflation in Microlaryngoscopies
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Professional decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \[finger device used in medicine\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.
Detailed Description:
High flow, low pressure oxygen will be supplied in microlaryngoscopy airway surgery. These procedures are usually performed with jet ventilation (UAB) or intermittent apnea (surgery centers). Jet ventilation provides oxygenation with limited ventilation but come with high risks, such as barotrauma, pneumothorax, mucosa drying, and even death in the most severe cases. Intermittent apnea is a nuisance for the surgeon in that surgical time is often interrupted with having to place the endotracheal tube whenever the patient's oxygen saturation levels fall. The solution is oxygen insufflation, which will give extended oxygenation times for the surgeon to operate without the inherent risks associated with jet ventilation. During the procedure, oxygen tubing will be connected to the surgeon's laryngoscope instead of the jet ventilation tubing. Oxygen flows of 15 L/min will be administered through the laryngoscope to the posterior oropharynx. Endotracheal tube will be placed if oxygenation deemed insufficient due to oxygen saturations of \<90%. Endotracheal tube will be intermittently placed to check and correct carbon dioxide levels.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: