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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.

Clinicaltrials.gov identifier NCT03946150

Recruitment Status Completed

First Posted May 10, 2019

Last update posted March 26, 2020

Study Description

Brief summary:

The PaO2/FiO2 (P/F) ratio is same for all the Positive End Expiratory Pressure (PEEP) ≥ to 5. This P/F ratio misleads the severity of disease without the knowledge of set PEEP. The Oxygenation status is actually worse when the patient is using high PEEP. P/F Ratio doesn't include PEEP in the calculation.The P/F ratio doesn't show the severity of the disease appropriate for the set PEEP. PaO2/(FiO2 X PEEP) P/FP Ratio is a new Formula which addresses this gap to appropriately calculate the severity of the disease by including PEEP in the formula. This formula is used to predict mortality for different severities of ARDS.

  • Condition or Disease:Adult Respiratory Distress Syndrome
  • Intervention/Treatment: Diagnostic Test: P/FP Ratio
  • Phase: N/A
Detailed Description

The Main aim of this study is to analyse whether this formula can early diagnose the severity of the disease appropriate for the set PEEP, so the Rescue measure can be started early which can eventually decreases the mortality. Increasing the PEEP Value with the same Fio2 gives a different PaO2 and SpO2. The oxygenation improves substantially by increasing only the PEEP. So including the PEEP in calculating the severity of Oxygenation is better than the current practice. The current Definition of ARDS for Oxygenation is P/F Ratio of 300 to 200 is Mild, 200 to 100 is Moderate and less than 100 is Severe ARDS with PEEP ≥ 5. The New P/FP Ratio of 300 to 200 is mild, 200 to 100 is moderate and less than 100 is severe Adult Respiratory Distress Syndrome (ARDS) for all the different levels of PEEP values.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 4361 participants
  • Observational Model: Case-Control
  • Time Perspective: Retrospective
  • Official Title: PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome
  • Actual Study Start Date: June 2017
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: P/F ratio
P/F ratio is the current Berlin definition of ARDS in Calculating the severity of Oxygenation.
Diagnostic Test: P/FP Ratio
PaO2/Fio2 X PEEP
: P/FP Ratio
P/FP Ratio is calculated in ARDS Patients retrospectively and analyse whether this new formula with PEEP can appropriately diagnose the Severity of Oxygenation with different levels of PEEP.
Diagnostic Test: P/FP Ratio
PaO2/Fio2 X PEEP
Outcome Measures
  • Primary Outcome Measures: 1. To predict mortality of ARDS patients using P/F and P/FP Ratio [ Time Frame: Baseline ABG done at (approximately 4 hour after intubation) to ABG done approximately 1 hour before Rescue therapy like Neuro Muscular blockage, Proning, ExtraCorporeal Membrane Oxygenator, and High Frequency Oscillatory Ventilation. ]
    To predict mortality of different seventies of ARDS between P/F and P/FP Ratio. Day 1 ABG is taken and calulate the P/F and P/FP Ratio and analyze whether the new formula can predict the mortality on Day 1 after intubation.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.
Criteria

Inclusion Criteria:

Intubated patients for

- Adult Respiratory Distress Syndrome

- Stroke

- Seizures

- Post neurosurgery

- Endoscopy Procedure

- Post Cardiac Collapse

Exclusion Criteria

Non intubated patients on

- Room Air

- Nasal Cannula

- Face mask

- Venturi Mask

- Non Rebreathing mask

Contacts and Locations
Contacts
Locations

Singapore
National Universty Health System
Singapore

Sponsors and Collaborators

National University Health System, Singapore

Investigators

Principal Investigator: Sunitha PalaniDurai National University Health System, Singapore

More Information
  • Responsible Party: National University Health System, Singapore
  • ClinicalTrials.gov Identifier: NCT03946150 History of Changes
  • Other Study ID Numbers: NUHSSingapore
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: March 26, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by National University Health System, Singapore: P/FP Ratio
    ARDS Definition
    Severity of Oxygenation in ARDS
  • Additional relevant MeSH terms: Respiratory Distress Syndrome, Newborn
    Respiratory Distress Syndrome, Adult
    Acute Lung Injury
    Syndrome