NCT04723017

Brief Summary

The primary aim was to develop and validation of perioperative hypoxemia using clinical big data and deep learning technique in pediatric patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 21, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 21, 2021

Last Update Submit

January 21, 2021

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

  • hypoxemia

    pulse oximetry desaturation below 95%

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

Interventions

Retrospective analysis cohortOTHER

We analyze pre-existing data base and develop machine-learning-based system that predicts the risk of hypoxemia

Prospective validation cohortOTHER

We validate our model to predict the risk of hypoxemia to prospective cohort

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients

You may qualify if:

  • Pediatric patients undergoing general or spinal anesthesia and monitored anesthesia care

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hee-Soo Kim, professor

CONTACT

+82-2-2072-3664dami0605@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 25, 2021

Study Start

January 21, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

KR(1)