Oxygen Reserve Index in Airway Surgery in Children

A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery

This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (<90%) in pediatric patients undergoing airway surgery.

Study Overview

• Status: Completed
• Conditions: Hypoxemia During Surgery
• Intervention / Treatment: Device: ORI monitoring

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pediatric patients receiving airway surgery

Exclusion Criteria:

• baseline oxygen saturation less than 95%
• patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ORI monitoring; SpO2, ECG, NIBP, and oxygen reserve index monitoring	Device: ORI monitoring; Oxygen reserve index monitoring during the surgery
No Intervention: Standard monitoring; SpO2, ECG, NIBP monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia	Oxygen desaturation <= 90%	from induction of anesthesia to end of operation, about 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia duration	Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation <= 90%)	from induction of anesthesia to end of operation, about 3 hours
Incidence and duration of severe hypoxemia	incidence and duration of oxygen desaturation <=85%	from induction of anesthesia to end of operation, about 3 hours
Rescue oxygenation	the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.	from induction of anesthesia to end of operation, about 3 hours
Hemodynamic instability	occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure	from induction of anesthesia to end of operation, about 3 hours
unexpected pediatric intensive care admission	requirements of unexpected pediatric intensive care admission	from induction of anesthesia to end of operation, about 3 hours
unanticipated postoperative mechanical support	Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen	from induction of anesthesia to end of operation, about 3 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2112-055-1281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No