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.

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Key information

Conditions

Adult Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Universty Health System

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P/FP Ratio

Diagnostic Test

PaO2/Fio2 X PEEP

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: May 10, 2019
Registry last updated: Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed