Body Roundness Index and Mortality in ICU Patients
NCT07631429
Body Composition, Body Weight
Samsun, Atakum, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT07301359
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
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Notify Me18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Time frame: From October 2025 to January 2026.............................................................................................................................................................................................................................
Death occurring during the ICU stay
Time frame: From October 2025 to January 2026
28-day all-cause mortality
Tanta University
Other
Association of the PaO₂/PaCO₂ Ratio With ICU Mortality Independent of Oxygen Saturation and Mean Arterial Pressure: Insights From the MIMIC-II Database
Acronym: RATIO-MIMIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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