NCT05371314

Brief Summary

Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

May 2, 2022

Last Update Submit

September 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Artificial intelligence in categorizing the severity of oxygenation of ARDS in ventilated patients

    To see the trend and difference between day 1, 2,3 and day 7 between P/F (PaO2/FiO2) and S/F(SaO2/FiO2) ratio to P/FP (PaO2/FiO2\*PEEP) ratio and S/FP (SpO2/(FiO2\*PEEP) ratio respectively.

    Baseline ABG done at (approximately 4 hour after intubation) to ABG done day 2,3 and day 7

Interventions

P/FP ratioDIAGNOSTIC_TEST

PaO2/FiO2 X PEEP, SpO2/FiO2 X PEEP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from MIMIC 4 and eICU

You may qualify if:

  • \. Intubated patients

You may not qualify if:

  • pediatric and neonates
  • DNR patients
  • Non intubated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Universty Health System

Singapore, Singapore

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 12, 2022

Study Start

December 1, 2021

Primary Completion

December 15, 2022

Study Completion

January 30, 2023

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations