Oxygen Insufflation in Microlaryngoscopies

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04979533
• Other study ID #: IRB-300007262
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria:

• patients who have a tracheostomy

Related Conditions & MeSH terms

• Hypoxia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures	15 liters per minute of oxygen will be administered to the posterior oropharynx.	30-60 minutes
Secondary	Degree of hypercapnia experienced by participants	Measurement will be taken by intermittent ventilation by placing an endotracheal tube	30-60 minutes
Secondary	Participants That Maintain Adequate Oxygenation at 90% or Greater	Pulse oximetry will be used to measure oxygenation status	30-60 minutes