Clinical trial NCT03946150: PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.
Official title: PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Respiratory Distress Syndrome
Keywords: P/FP Ratio
ARDS Definition
Severity of Oxygenation in ARDS
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 4361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.

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.

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.

Eligibility 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

Primary outcomes:
measure: To predict mortality of ARDS patients using P/F and P/FP Ratio
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Universty Health System
Study officials:
affiliation: National University Health System, Singapore
name: Sunitha PalaniDurai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.