Back to resultsEfficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High-flow nasal oxygen
Low-flow nasal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- adult patients aged over 19 years who are scheduled for sleep endoscopy
Exclusion Criteria:
- 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-flow nasal oxygen during sleep endoscopy
Low-flow nasal oxygen during sleep endoscopy
Arm Description
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Outcomes
Primary Outcome Measures
oxygen saturation value
Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03777202
Brief Title
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Official Title
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flow nasal oxygen during sleep endoscopy
Arm Type
Experimental
Arm Description
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Arm Title
Low-flow nasal oxygen during sleep endoscopy
Arm Type
Active Comparator
Arm Description
Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Intervention Type
Procedure
Intervention Name(s)
High-flow nasal oxygen
Intervention Description
High-flow nasal oxygen will be applied to the patients using Optiflow system through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Low-flow nasal oxygen
Intervention Description
Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Primary Outcome Measure Information:
Title
oxygen saturation value
Description
Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure.
Time Frame
For 15 minutes during sleep endoscopy. At Day 0.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients aged over 19 years who are scheduled for sleep endoscopy
Exclusion Criteria:
1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Kim
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
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