Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

NCT03777202 | Completed

• 1 other identifier: 4-2018-0923
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• oxygen saturation value

  Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure.

  For 15 minutes during sleep endoscopy. At Day 0.

Study Arms (2)

High-flow nasal oxygen during sleep endoscopy

EXPERIMENTAL

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.

Procedure: High-flow nasal oxygen

Low-flow nasal oxygen during sleep endoscopy

ACTIVE COMPARATOR

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.

Procedure: Low-flow nasal oxygen

Interventions

High-flow nasal oxygen PROCEDURE

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.

High-flow nasal oxygen during sleep endoscopy

Low-flow nasal oxygen PROCEDURE

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.

Low-flow nasal oxygen during sleep endoscopy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged over 19 years who are scheduled for sleep endoscopy

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Hyun Joo Kim

  Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: July 17, 2020
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

KR (1)