NCT05214950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

January 18, 2022

Last Update Submit

April 20, 2023

Conditions

Hypoxemia During Surgery

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

    Oxygen desaturation \<= 90%

    from induction of anesthesia to end of operation, about 3 hours

Secondary Outcomes (6)

  • Hypoxemia duration

    from induction of anesthesia to end of operation, about 3 hours

  • Incidence and duration of severe hypoxemia

    from induction of anesthesia to end of operation, about 3 hours

  • Rescue oxygenation

    from induction of anesthesia to end of operation, about 3 hours

  • Hemodynamic instability

    from induction of anesthesia to end of operation, about 3 hours

  • unexpected pediatric intensive care admission

    from induction of anesthesia to end of operation, about 3 hours

  • +1 more secondary outcomes

Study Arms (2)

ORI monitoring

EXPERIMENTAL

SpO2, ECG, NIBP, and oxygen reserve index monitoring

Device: ORI monitoring

Standard monitoring

NO INTERVENTION

SpO2, ECG, NIBP monitoring

Interventions

ORI monitoringDEVICE

Oxygen reserve index monitoring during the surgery

ORI monitoring

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pediatric patients receiving airway surgery

You may not qualify if:

  • baseline oxygen saturation less than 95%
  • patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

January 18, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Locations

KR(1)