Oxygen Reserve Index in Airway Surgery in Children

Hypoxemia During Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214950
• Other study ID #: 2112-055-1281
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia During Surgery
• Hypoxia

Intervention

Device:
• ORI monitoring
Oxygen reserve index monitoring during the surgery

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	Oxygen desaturation <= 90%	from induction of anesthesia to end of operation, about 3 hours
Secondary	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
Secondary	Incidence and duration of severe hypoxemia	incidence and duration of oxygen desaturation <=85%	from induction of anesthesia to end of operation, about 3 hours
Secondary	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
Secondary	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
Secondary	unexpected pediatric intensive care admission	requirements of unexpected pediatric intensive care admission	from induction of anesthesia to end of operation, about 3 hours
Secondary	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