Oxygen Insufflation in Microlaryngoscopies

NCT ID: NCT04979533

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-05-30

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.

Conditions

Hypoxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Oxygen Insufflation

Oxygen insufflation via oxygen tubing at 15 L/min

Group Type: EXPERIMENTAL

Insufflator oxygen tubing

Intervention Type: DEVICE

high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Flexible Oxygen tubing

Eligibility Criteria

Inclusion Criteria

• adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria

• patients who have a tracheostomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Hollie Sanders

Certified Registered Nurse Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hollie N Sanders, MSN

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

IRB-300007262

Identifier Type: -

Identifier Source: org_study_id