ARDSP/FP ratioNCT05371314
Artificial Intelligence in Categorizing the Severity of Oxygenation by Incorporating the PEEP Into the Definition of ARDS in Ventilated Patients
An observational study of ARDS, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS
- What is being tested?
- P/FP ratio
- How many people
- 5,000 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2021to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from MIMIC 4 and eICU
Who may be able to join
- 1. Intubated patients
Who cannot join
- pediatric and neonates
- DNR patients
- Non intubated patients
Trial locations and contacts
1 site in 1 country.
About this study
Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio
- Conditions
- ARDS
- Being tested
- P/FP ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P/FP ratioDiagnostic test
PaO2/FiO2 X PEEP, SpO2/FiO2 X PEEP
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline ABG done at (approximately 4 hour after intubation) to ABG done day 2,3 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Dec 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunitha PalaniDurai, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371314
- Sponsor's protocol ID
- NUHS
- Acronym
- P/FP ratio
- Status last verified
- Sep 2022
- First submitted
- 2 May 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Categorizing the Severity of Oxygenation by Incorporating the PEEP Into the Definition of ARDS in Ventilated Patients
- ClinicalTrials.gov ID
- NCT05371314
- Acronym / sponsor ID
- P/FP ratio / NUHS
- Conditions
- ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Artificial Intelligence in categorizing the severity of Oxygen in ventilated patients to predict initiation of treatment measures to improve mortality - P/FP ratio
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from MIMIC 4 and eICU
Key inclusion criteria (1 listed)
- 1. Intubated patients
Key exclusion criteria (3 listed)
- pediatric and neonates
- DNR patients
- Non intubated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P/FP ratioPaO2/FiO2 X PEEP, SpO2/FiO2 X PEEP | Diagnostic test | – |
Primary outcome
Artificial intelligence in categorizing the severity of oxygenation of ARDS in ventilated patients
Time frame: Baseline ABG done at (approximately 4 hour after intubation) to ABG done day 2,3 and day 7
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Artificial intelligence in categorizing the severity of oxygenation of ARDS in ventilated patients (time frame: Baseline ABG done at (approximately 4 hour after intubation) to ABG done day 2,3 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.