Oxygen Reserve Index in Airway Surgery in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypoxemia During Surgery

Intervention / Treatment
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* Device: ORI monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ORI monitoring<br>SpO2, ECG, NIBP, and oxygen reserve index monitoring | Device: ORI monitoring<br>* Oxygen reserve index monitoring during the surgery<br>|
| No Intervention: Standard monitoring<br>SpO2, ECG, NIBP monitoring | |

What is the study measuring?
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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 |