Oxygen Reserve Index in Airway Surgery in Children

NCT ID: NCT05214950

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-03-30

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.

Detailed Description

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Conditions

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Hypoxemia During Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ORI monitoring

SpO2, ECG, NIBP, and oxygen reserve index monitoring

Group Type EXPERIMENTAL

ORI monitoring

Intervention Type DEVICE

Oxygen reserve index monitoring during the surgery

Standard monitoring

SpO2, ECG, NIBP monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ORI monitoring

Oxygen reserve index monitoring during the surgery

Intervention Type DEVICE

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jin-Tae Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2112-055-1281

Identifier Type: -

Identifier Source: org_study_id

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