Oxygen Insufflation in Microlaryngoscopies

Not Applicable

Withdrawn

• Conditions: Hypoxia
• Interventions: Device: Insufflator oxygen tubing

• Registration Number: NCT04979533
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-28
• Status Verified: 2023-01
• Study Start: 2023-01-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• adult patients undergoing microlaryngoscopy surgery without a tracheostomy

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Exclusion Criteria

• patients who have a tracheostomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxygen Insufflation	Insufflator oxygen tubing	Oxygen insufflation via oxygen tubing at 15 L/min

Primary Outcome Measures

Name	Time	Method
High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures	30-60 minutes	15 liters per minute of oxygen will be administered to the posterior oropharynx.

Secondary Outcome Measures

Name	Time	Method
Degree of hypercapnia experienced by participants	30-60 minutes	Measurement will be taken by intermittent ventilation by placing an endotracheal tube
Participants That Maintain Adequate Oxygenation at 90% or Greater	30-60 minutes	Pulse oximetry will be used to measure oxygenation status