NCT04527094

Brief Summary

The main objective of this study is to develop a machine learning model that predicts postoperative respiratory failure within 7 postoperative day using a real-world, local preoperative and intraoperative electronic health records, not administrative codes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

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

August 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 21, 2020

Last Update Submit

August 29, 2022

Conditions

Keywords

Artificial IntelligenceRisk FactorsPostoperative respiratory failureValidation

Outcome Measures

Primary Outcomes (1)

  • the incidence of postoperative respiratory failure after general anesthesia

    Postoperative respiratory failure which was defined as mechanical ventilation \>48 h or any reintubation after surgery

    within postoperative day 7

Study Arms (1)

AI_PRF

Adults patients undergoing general anesthesia

Diagnostic Test: Prediction of postoperative respiratory failure using a machine learning

Interventions

The performance of a machine learning model to predict postoperative respiratory failure after general anesthesia within postoperative day 7 was tested prospectively.

AI_PRF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing general anesthesia for noncardiac surgery

You may qualify if:

  • Adults patients undergoing general anesthesia for noncardiac surgery

You may not qualify if:

  • Age under 18 years
  • Surgery duration \< 1 hr
  • Cardiac surgery
  • Surgery performed only regional or local anesthesia, peripheral nerve block, or monitored anesthesia care
  • Organ transplantation
  • Patient with preoperative tracheal intubation
  • Patients who had tracheostoma prior to surgery
  • Patients scheduled for tracheostomy
  • Surgery performed outside the operating room
  • Length of hospital stay \< 24 h
  • If the patients had multiple surgeries during the same hospital stays, we included the first surgical cases in the dataset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyun-Kyu Yoon

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 26, 2020

Study Start

May 26, 2021

Primary Completion

May 25, 2022

Study Completion

June 25, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations