Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
Study NCT ID:
NCT03946150
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2019-05-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4361}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['P/FP Ratio', 'ARDS Definition', 'Severity of Oxygenation in ARDS'], 'conditions': ['Adult Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '34370116', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nP/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.\n\nPaO2/(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.\n\nThis formula is used to predict mortality for different severities of ARDS.", 'detailedDescription': '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.\n\nIncreasing 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIntubated patients for\n\n* Adult Respiratory Distress Syndrome\n* Stroke\n* Seizures\n* Post neurosurgery\n* Endoscopy Procedure\n* Post Cardiac Collapse\n\nExclusion Criteria\n\nNon intubated patients on\n\n* Room Air\n* Nasal Cannula\n* Face mask\n* Venturi Mask\n* Non Rebreathing mask'}, 'identificationModule': {'nctId': 'NCT03946150', 'briefTitle': 'PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'National University Health System, Singapore'}, 'officialTitle': 'PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'NUHSSingapore'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'P/FP Ratio', 'description': '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.', 'interventionNames': ['Diagnostic Test: P/FP Ratio']}, {'label': 'P/F ratio', 'description': 'P/F ratio is the current Berlin definition of ARDS in Calculating the severity of Oxygenation.', 'interventionNames': ['Diagnostic Test: P/FP Ratio']}], 'interventions': [{'name': 'P/FP Ratio', 'type': 'DIAGNOSTIC_TEST', 'description': 'PaO2/Fio2 X PEEP', 'armGroupLabels': ['P/F ratio', 'P/FP Ratio']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Universty Health System', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Sunitha PalaniDurai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Health System, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Health System, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sunitha PalaniDurai', 'investigatorAffiliation': 'National University Health System, Singapore'}}}}