Oxygen Insufflation in Microlaryngoscopies

January 24, 2023 updated by: Hollie Sanders, University of Alabama at Birmingham

Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria:

  • patients who have a tracheostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen Insufflation
Oxygen insufflation via oxygen tubing at 15 L/min
Device: Insufflator oxygen tubing
high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.
Other Names:
  • Flexible Oxygen tubing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Hollie N Sanders, MSN, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300007262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The oxygen saturation numbers throughout each surgery will be recorded with no personal identifying data of each patient.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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