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

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ClinicalTrials.gov Identifier: NCT03777202
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Study of high-flow nasal oxygen in obstructive sleep apnea patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-flow nasal oxygen during sleep endoscopy
High-flow nasal oxygen will be applied to the patients through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
Device: Study of high-flow nasal oxygen in obstructive sleep apnea patients
High-flow nasal oxygen will be applied to the patients through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.




Primary Outcome Measures :
  1. oxygen saturation value [ Time Frame: For 15 minutes during sleep endoscopy. At Day 0. ]
    Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03777202


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03777202     History of Changes
Other Study ID Numbers: 4-2018-0923
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases