- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07301359
Is the PaO₂/PaCO₂ Ratio Associated With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure? (RATIO-MIMIC)
Association of the PaO₂/PaCO₂ Ratio With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure: Insights From the MIMIC-II Database
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
All 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.
Patients were excluded if they lacked valid PaO₂ or PaCO₂ measurements, had missing ICU mortality data, or had physiologically impla
Description
Inclusion criteria
Adult patients (≥ 18 years old) at time of ICU admission. Rationale: Restrict to adult physiology and consent/ethics comparability.
First ICU stay during hospital admission (index ICU admission). Rationale: Avoid within-hospital dependency and repeated measures bias.
ICU admission captured in the MIMIC-II dataset between the database start and end dates.
Rationale: Use all eligible records within the dataset timeframe.
At least one arterial blood gas (ABG) measurement with both PaO₂ and PaCO₂ available during the ICU stay.
Rationale: Primary exposure is PaO₂/PaCO₂ ratio; require both values to compute it.
Available outcome data for ICU mortality (discharge status from ICU). Rationale: Necessary to ascertain primary endpoint.
Available SpO₂ and mean arterial pressure (MAP) measurements in the same ICU stay (for confounder adjustment).
Rationale: 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.)
Exclusion criteria
Age < 18 years. Rationale: Exclude pediatric physiology.
Missing or unusable arterial blood gas values (PaO₂ or PaCO₂ absent or non-numeric) for the ICU stay.
Rationale: Cannot compute exposure.
No recorded ICU outcome (missing ICU discharge status) or lost/invalid mortality data.
Rationale: Cannot determine primary outcome.
Extreme 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).
Rationale: Remove likely data-entry errors. Document thresholds and perform sensitivity analysis.
Patients on extracorporeal life support (ECMO) during ABG measurement (if identifiable in MIMIC-II).
Rationale: ECMO profoundly alters gas exchange and PaO₂/PaCO₂ physiology; consider exclusion or separate subgroup.
Repeat ICU admissions within the same hospital stay beyond the index admission (if you choose to restrict to single index admission).
Rationale: Prevent correlated observations - include only the first ICU stay per hospital admission.
ICU stays with no recorded SpO₂ or MAP at any time (if you insist on requiring these for adjustment).
Rationale: If primary models must adjust for SpO₂ and MAP, exclude records without those covariates or plan appropriate imputation.
Do-not-resuscitate (DNR)/comfort-care only status recorded before ABG measurement (optional exclusion depending on study question).
Rationale: Treatment limitation orders can confound mortality associations; you may choose instead to adjust or analyze separately.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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The Indwelling Arterial Catheter Clinical dataset contains clinical data for 1776 patients..........
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......................................................................................................................................................................................................................................................................................................................................................................................................................................................................
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU mortality
Time Frame: From October 2025 to January 2026.............................................................................................................................................................................................................................
|
Death occurring during the ICU stay
|
From October 2025 to January 2026.............................................................................................................................................................................................................................
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
28-day all-cause mortality
Time Frame: From October 2025 to January 2026
|
28-day all-cause mortality
|
From October 2025 to January 2026
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MIMIC-II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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