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

NCT04291339 | Completed

• 1 other identifier: 4-2019-1336
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The time to achieve the peak oxygen reserve index value

  for 10 minutes during anesthetic induction. At Day 0.

Study Arms (2)

High-flow nasal oxygen technique

EXPERIMENTAL

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.

Procedure: High-flow nasal oxygen technique

Mask ventilation technique

ACTIVE COMPARATOR

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.

Procedure: Mask ventilation technique

Interventions

High-flow nasal oxygen technique PROCEDURE

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.

High-flow nasal oxygen technique

Mask ventilation technique PROCEDURE

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.

Mask ventilation technique

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
• facial anomaly
• consciousness disorder
• Risk of aspiration
• necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Related Publications (1)

• Park S, Kim SY, Kim MS, Park WK, Byon HJ, Kim HJ. Comparison of preoxygenation efficiency measured by the oxygen reserve index between high-flow nasal oxygenation and facemask ventilation: a randomised controlled trial. BMC Anesthesiol. 2023 May 9;23(1):159. doi: 10.1186/s12871-023-02126-9.

  PMID: 37161369 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 2, 2020
• Study Start: November 11, 2020
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)