Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-08 @ 2:12 AM
Study NCT ID:
NCT07301359
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the PaO₂/PaCO₂ Ratio Associated With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-27', 'size': 316480, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-26T17:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1776}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2016-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'From October 2025 to January 2026.............................................................................................................................................................................................................................', 'description': 'Death occurring during the ICU stay'}], 'secondaryOutcomes': [{'measure': '28-day all-cause mortality', 'timeFrame': 'From October 2025 to January 2026', 'description': '28-day all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mortality in Intensive Care Units']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the Association of the PaO₂/PaCO₂ Ratio with ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included adult patients admitted to intensive care units (ICUs) represented in the Medical Information Mart for Intensive Care II (MIMIC-II) database, a large, publicly available critical care database developed by the Massachusetts Institute of Technology (MIT) in collaboration with Beth Israel Deaconess Medical Center (BIDMC). The database contains detailed, de-identified clinical data from patients admitted to the BIDMC ICUs between 2001 and 2008.\n\nAll adult (≥18 years) ICU patients with at least one arterial blood gas measurement containing both arterial oxygen tension (PaO₂) and arterial carbon dioxide tension (PaCO₂) were eligible for inclusion. For each included ICU stay, corresponding measurements of oxygen saturation (SpO₂) and mean arterial pressure (MAP) were also extracted to allow adjustment for oxygenation and hemodynamic status.\n\nPatients were excluded if they lacked valid PaO₂ or PaCO₂ measurements, had missing ICU mortality data, or had physiologically impla', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\nAdult patients (≥ 18 years old) at time of ICU admission. Rationale: Restrict to adult physiology and consent/ethics comparability.\n\nFirst ICU stay during hospital admission (index ICU admission). Rationale: Avoid within-hospital dependency and repeated measures bias.\n\nICU admission captured in the MIMIC-II dataset between the database start and end dates.\n\nRationale: Use all eligible records within the dataset timeframe.\n\nAt least one arterial blood gas (ABG) measurement with both PaO₂ and PaCO₂ available during the ICU stay.\n\nRationale: Primary exposure is PaO₂/PaCO₂ ratio; require both values to compute it.\n\nAvailable outcome data for ICU mortality (discharge status from ICU). Rationale: Necessary to ascertain primary endpoint.\n\nAvailable SpO₂ and mean arterial pressure (MAP) measurements in the same ICU stay (for confounder adjustment).\n\nRationale: Study aims to evaluate independence from SpO₂ and MAP; require at least one measurement of each during the stay. (If either is missing, see handling below.)\n\nExclusion criteria\n\nAge \\< 18 years. Rationale: Exclude pediatric physiology.\n\nMissing or unusable arterial blood gas values (PaO₂ or PaCO₂ absent or non-numeric) for the ICU stay.\n\nRationale: Cannot compute exposure.\n\nNo recorded ICU outcome (missing ICU discharge status) or lost/invalid mortality data.\n\nRationale: Cannot determine primary outcome.\n\nExtreme or physiologically implausible ABG values that suggest data error (e.g., PaO₂ ≤ 0 mmHg, PaCO₂ ≤ 0 mmHg, or PaO₂ \\> 1000 mmHg or PaCO₂ \\> 300 mmHg - thresholds may be tightened after exploratory data review).\n\nRationale: Remove likely data-entry errors. Document thresholds and perform sensitivity analysis.\n\nPatients on extracorporeal life support (ECMO) during ABG measurement (if identifiable in MIMIC-II).\n\nRationale: ECMO profoundly alters gas exchange and PaO₂/PaCO₂ physiology; consider exclusion or separate subgroup.\n\nRepeat ICU admissions within the same hospital stay beyond the index admission (if you choose to restrict to single index admission).\n\nRationale: Prevent correlated observations - include only the first ICU stay per hospital admission.\n\nICU stays with no recorded SpO₂ or MAP at any time (if you insist on requiring these for adjustment).\n\nRationale: If primary models must adjust for SpO₂ and MAP, exclude records without those covariates or plan appropriate imputation.\n\nDo-not-resuscitate (DNR)/comfort-care only status recorded before ABG measurement (optional exclusion depending on study question).\n\nRationale: Treatment limitation orders can confound mortality associations; you may choose instead to adjust or analyze separately.'}, 'identificationModule': {'nctId': 'NCT07301359', 'acronym': 'RATIO-MIMIC', 'briefTitle': 'Is the PaO₂/PaCO₂ Ratio Associated With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure?', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Association of the PaO₂/PaCO₂ Ratio With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure: Insights From the MIMIC-II Database', 'orgStudyIdInfo': {'id': 'MIMIC-II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The Indwelling Arterial Catheter Clinical dataset contains clinical data for 1776 patients..........', 'description': 'The Indwelling Arterial Catheter Clinical dataset contains clinical data for 1776 patients from the MIMIC-II clinical database. It was the basis for the article: Hsu DJ, et al. The association between indwelling arterial catheters and mortality in hemodynamically stable patients with respiratory failure: A propensity score analysis. Chest, 148(6):1470-1476, Aug. 2015.This dataset was also used by Raffa et al. in Chapter 5 "Data Analysis" of the forthcoming book: Secondary Analysis of Electronic Health Records, published by Springer in 2016......................................................................................................................................................................................................................................................................................................................................................................................................................................................................'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Mohammed F Abosamak 1.... Department of Anesthesia and Intensive Care Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt 2....Department of adults ICU, Security Forces Hospital Program, Central Directorate Of Medical Services , Riyadh, KSA', 'investigatorFullName': 'MOHAMMED FAWZI ALI ABOSAMAK', 'investigatorAffiliation': 'Tanta University'}}}}