Oxygen Insufflation in Microlaryngoscopies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxia

Intervention / Treatment
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* Device: Insufflator oxygen tubing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients undergoing microlaryngoscopy surgery without a tracheostomy Exclusion Criteria: patients who have a tracheostomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: There will be a single group of participants in which all receive oxygen insufflation to see if oxygen insufflation is adequate in microlaryngoscopy airway surgery.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, airway, hypoxia prevention, oxygen insufflation