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

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

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.

Study Overview

• Status: Completed
• Conditions: Adult Respiratory Distress Syndrome
• Intervention / Treatment: Diagnostic test: P/FP Ratio

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 Type: Observational
• Enrollment (Actual): 4361

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National Universty Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To predict mortality of ARDS patients using P/F and P/FP Ratio	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.	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.

Collaborators and Investigators

• Sponsor: National University Health System, Singapore
• Investigators: Principal Investigator: Sunitha PalaniDurai, National University Health System, Singapore

Publications and helpful links

General Publications

• Palanidurai S, Phua J, Chan YH, Mukhopadhyay A. P/FP ratio: incorporation of PEEP into the PaO2/FiO2 ratio for prognostication and classification of acute respiratory distress syndrome. Ann Intensive Care. 2021 Aug 9;11(1):124. doi: 10.1186/s13613-021-00908-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: P/FP Ratio; ARDS Definition; Severity of Oxygenation in ARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: NUHSSingapore

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No