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

Completed

• Conditions: Adult Respiratory Distress Syndrome
• Interventions: Diagnostic Test: P/FP Ratio

• Registration Number: NCT03946150
• Lead Sponsor: National University Health System, Singapore

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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2019-05-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Status Verified: 2020-03
• Study Completion: 2020-03-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4361

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P/FP Ratio	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.
P/F ratio	P/FP Ratio	P/F ratio is the current Berlin definition of ARDS in Calculating the severity of Oxygenation.

Primary Outcome Measures

Name	Time	Method
To predict mortality of ARDS patients using P/F and P/FP Ratio	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.

Trial Locations

Locations (1)

National Universty Health System; 🇸🇬 Singapore, Singapore