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

NCT03946150 | Completed DMC

• 1 other identifier: NUHSSingapore
• Study Type: observational
• Target: 4,361
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Respiratory Distress Syndrome

Keywords

P/FP Ratio; ARDS Definition; Severity of Oxygenation in ARDS

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

P/F ratio

P/F ratio is the current Berlin definition of ARDS in Calculating the severity of Oxygenation.

Diagnostic Test: P/FP Ratio

Interventions

P/FP Ratio DIAGNOSTIC_TEST

PaO2/Fio2 X PEEP

P/F ratio; P/FP Ratio

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Intubated patients for
• Adult Respiratory Distress Syndrome
• Stroke
• Seizures
• Post neurosurgery
• Endoscopy Procedure
• Post Cardiac Collapse

You may not qualify if:

• Non intubated patients on
• Room Air
• Nasal Cannula
• Face mask
• Venturi Mask
• Non Rebreathing mask

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

National Universty Health System

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34370116 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Sunitha PalaniDurai

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2017
• Primary Completion: May 5, 2019
• Study Completion: March 3, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)