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

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ClinicalTrials.gov Identifier: NCT03946150
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Sunitha PalaniDurai, 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.


Condition or disease Intervention/treatment
Adult Respiratory Distress Syndrome 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.

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Study Type : Observational
Actual Enrollment : 4361 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : March 3, 2020


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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946150


Locations
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Singapore
National Universty Health System
Singapore, Singapore
Sponsors and Collaborators
National University Health System, Singapore
Investigators
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Principal Investigator: Sunitha PalaniDurai National University Health System, Singapore
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Responsible Party: Sunitha PalaniDurai, Principal Investigator, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT03946150    
Other Study ID Numbers: NUHSSingapore
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunitha PalaniDurai, National University Health System, Singapore:
P/FP Ratio
ARDS Definition
Severity of Oxygenation in ARDS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury