Back to resultsOxygen Reserve Index in Airway Surgery in Children
Primary Purpose
Hypoxemia During Surgery
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ORI monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxemia During Surgery
Eligibility Criteria
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
Sites / Locations
- Jin-Tae Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ORI monitoring
Standard monitoring
Arm Description
SpO2, ECG, NIBP, and oxygen reserve index monitoring
SpO2, ECG, NIBP monitoring
Outcomes
Primary Outcome Measures
Hypoxemia
Oxygen desaturation <= 90%
Secondary Outcome Measures
Hypoxemia duration
Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation <= 90%)
Incidence and duration of severe hypoxemia
incidence and duration of oxygen desaturation <=85%
Rescue oxygenation
the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.
Hemodynamic instability
occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure
unexpected pediatric intensive care admission
requirements of unexpected pediatric intensive care admission
unanticipated postoperative mechanical support
Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen
Full Information
NCT ID
NCT05214950
First Posted
January 18, 2022
Last Updated
April 20, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05214950
Brief Title
Oxygen Reserve Index in Airway Surgery in Children
Official Title
A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia During Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ORI monitoring
Arm Type
Experimental
Arm Description
SpO2, ECG, NIBP, and oxygen reserve index monitoring
Arm Title
Standard monitoring
Arm Type
No Intervention
Arm Description
SpO2, ECG, NIBP monitoring
Intervention Type
Device
Intervention Name(s)
ORI monitoring
Intervention Description
Oxygen reserve index monitoring during the surgery
Primary Outcome Measure Information:
Title
Hypoxemia
Description
Oxygen desaturation <= 90%
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Secondary Outcome Measure Information:
Title
Hypoxemia duration
Description
Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation <= 90%)
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Title
Incidence and duration of severe hypoxemia
Description
incidence and duration of oxygen desaturation <=85%
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Title
Rescue oxygenation
Description
the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Title
Hemodynamic instability
Description
occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Title
unexpected pediatric intensive care admission
Description
requirements of unexpected pediatric intensive care admission
Time Frame
from induction of anesthesia to end of operation, about 3 hours
Title
unanticipated postoperative mechanical support
Description
Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen
Time Frame
from induction of anesthesia to end of operation, about 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Oxygen Reserve Index in Airway Surgery in Children
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