Oxygen Reserve Index in Airway Surgery in Children

Not Applicable

Completed

• Conditions: Hypoxemia During Surgery
• Interventions: Device: ORI monitoring

• Registration Number: NCT05214950
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORI monitoring	ORI monitoring	SpO2, ECG, NIBP, and oxygen reserve index monitoring

Primary Outcome Measures

Name	Time	Method
Hypoxemia	from induction of anesthesia to end of operation, about 3 hours	Oxygen desaturation \<= 90%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of