Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction

Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia Clinical Trial

Official title:

Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291339
• Other study ID #: 4-2019-1336
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: January 12, 2021

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• basal skull fracture

• facial anomaly

• consciousness disorder

• Risk of aspiration

• necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.

Related Conditions & MeSH terms

• Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia

Intervention

Procedure:
• High-flow nasal oxygen technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
• Mask ventilation technique
Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen reserve index value	Oxygen reserve index will be monitored continuously during anesthetic induction.	for 10 minutes during anesthetic induction. At Day 0.
Secondary	The time to achieve the peak oxygen reserve index value	Oxygen reserve index will be monitored continuously during anesthetic induction.	for 10 minutes during anesthetic induction. At Day 0.