Back to resultsOxygen Insufflation in Microlaryngoscopies
Primary Purpose
Hypoxia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insufflator oxygen tubing
Sponsored by
About this trial
This is an interventional device feasibility trial for Hypoxia focused on measuring surgery, airway, hypoxia prevention, oxygen insufflation
Eligibility Criteria
Inclusion Criteria:
- adult patients undergoing microlaryngoscopy surgery without a tracheostomy
Exclusion Criteria:
- patients who have a tracheostomy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxygen Insufflation
Arm Description
Oxygen insufflation via oxygen tubing at 15 L/min
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Degree of hypercapnia experienced by participants
Measurement will be taken by intermittent ventilation by placing an endotracheal tube
Participants That Maintain Adequate Oxygenation at 90% or Greater
Pulse oximetry will be used to measure oxygenation status
Full Information
NCT ID
NCT04979533
First Posted
June 29, 2021
Last Updated
January 24, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04979533
Brief Title
Oxygen Insufflation in Microlaryngoscopies
Official Title
Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Professional decision
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
surgery, airway, hypoxia prevention, oxygen insufflation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Insufflation
Arm Type
Experimental
Arm Description
Oxygen insufflation via oxygen tubing at 15 L/min
Intervention Type
Device
Intervention Name(s)
Insufflator oxygen tubing
Other Intervention Name(s)
Flexible Oxygen tubing
Intervention Description
high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.
Primary Outcome Measure Information:
Title
High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures
Description
15 liters per minute of oxygen will be administered to the posterior oropharynx.
Time Frame
30-60 minutes
Secondary Outcome Measure Information:
Title
Degree of hypercapnia experienced by participants
Description
Measurement will be taken by intermittent ventilation by placing an endotracheal tube
Time Frame
30-60 minutes
Title
Participants That Maintain Adequate Oxygenation at 90% or Greater
Description
Pulse oximetry will be used to measure oxygenation status
Time Frame
30-60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
adult patients undergoing microlaryngoscopy surgery without a tracheostomy
Exclusion Criteria:
patients who have a tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie N Sanders, MSN
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The oxygen saturation numbers throughout each surgery will be recorded with no personal identifying data of each patient.
Learn more about this trial
Oxygen Insufflation in Microlaryngoscopies
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