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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05214950
Enrollment
88
Registered
2022-01-31
Start date
2022-01-18
Completion date
2023-03-30
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia During Surgery

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.

Interventions

DEVICEORI monitoring

Oxygen reserve index monitoring during the surgery

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hypoxemiafrom induction of anesthesia to end of operation, about 3 hoursOxygen desaturation \<= 90%

Secondary

MeasureTime frameDescription
Incidence and duration of severe hypoxemiafrom induction of anesthesia to end of operation, about 3 hoursincidence and duration of oxygen desaturation \<=85%
Rescue oxygenationfrom induction of anesthesia to end of operation, about 3 hoursthe number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.
Hypoxemia durationfrom induction of anesthesia to end of operation, about 3 hoursTotal length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation \<= 90%)
unexpected pediatric intensive care admissionfrom induction of anesthesia to end of operation, about 3 hoursrequirements of unexpected pediatric intensive care admission
unanticipated postoperative mechanical supportfrom induction of anesthesia to end of operation, about 3 hoursRequirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen
Hemodynamic instabilityfrom induction of anesthesia to end of operation, about 3 hoursoccurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026