NCT07301359

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,776

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2016

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 10, 2025

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    Death occurring during the ICU stay

    From October 2025 to January 2026.............................................................................................................................................................................................................................

Secondary Outcomes (1)

  • 28-day all-cause mortality

    From October 2025 to January 2026

Study Arms (1)

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......................................................................................................................................................................................................................................................................................................................................................................................................................................................................

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.)

You may not qualify if:

  • 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).
  • 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.
  • Rationale: Treatment limitation orders can confound mortality associations; you may choose instead to adjust or analyze separately.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 24, 2025

Study Start

March 20, 2015

Primary Completion

March 20, 2016

Study Completion

March 20, 2016

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share