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Oxygen Insufflation in Microlaryngoscopies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979533
Recruitment Status : Withdrawn (Professional decision)
First Posted : July 28, 2021
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Hollie Sanders, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypoxia Device: Insufflator oxygen tubing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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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 Name: Flexible Oxygen tubing


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Degree of hypercapnia experienced by participants [ Time Frame: 30-60 minutes ]
    Measurement will be taken by intermittent ventilation by placing an endotracheal tube

  2. Participants That Maintain Adequate Oxygenation at 90% or Greater [ Time Frame: 30-60 minutes ]
    Pulse oximetry will be used to measure oxygenation status


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion Criteria:

  • patients who have a tracheostomy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979533


Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Hollie N Sanders, MSN University of Alabama at Birmingham
More Information
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Responsible Party: Hollie Sanders, Certified Registered Nurse Anesthetist, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04979533    
Other Study ID Numbers: IRB-300007262
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The oxygen saturation numbers throughout each surgery will be recorded with no personal identifying data of each patient.

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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
Keywords provided by Hollie Sanders, University of Alabama at Birmingham:
surgery
airway
hypoxia prevention
oxygen insufflation
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory