- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484828
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm (VentilO CU)
This study aims to better understand how mechanical ventilation settings affect patients admitted to the coronary care unit after cardiac arrest or with cardiogenic shock. These patients often require mechanical ventilation, but current guidelines provide limited evidence on the best approach. Improper ventilation settings can lead to acid-base imbalances, such as respiratory acidosis or alkalosis, which may worsen patient outcomes.
The retrospective analysis will include 100 adult patients (50 post-cardiac arrest and 50 with cardiogenic shock) who were mechanically ventilated upon admission. The study has two main objectives:
Determine how often acid-base disorders occur in these patients and describe their characteristics.
Compare the initial ventilator settings chosen by clinicians with those suggested by VentilO, a decision-support algorithm.
The investigators will evaluate the potential effect of the VentilO recommendations on the first arterial (or capillary) blood gases compared to the real settings.
This information will help refine the algorithm and guide future research on improving ventilation strategies for critically ill cardiac patients.
Participation does not involve any intervention, as the study uses existing medical records.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francois Lellouche
- Phone Number: 3572 1-418-656-8711
- Email: francois.lellouche@criucpq.ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (Age >=18 years old)
- Under mechanical ventilation with endotracheal tube for :
post cardiac arrest or cardiogenic shock
- Bood gases result availability up to 4 hours after coronary unit admission
Exclusion Criteria:
- Lack of patient anthropometric data (height and weight) available in the patient record
- No information in the record regarding the data on the humidification systems used at the time of the first blood gas test upon admission to the coronary care unit.
- Patient stabilzed in other hospital before coronary unit admission or adjustment of respiratory parameters after a blood gas test.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient post cardiac arrest
|
Blood gases evaluation after initiation of mechanical ventilation
|
|
Patient with cardiogenic shock
|
Blood gases evaluation after initiation of mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acid-base disorder (respiratory acidosis)
Time Frame: Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Presence of respiratory acisosis define by pH< 7.35 and PaCO2 > 45 mmHg
|
Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
|
Acid-base disorder (respiratory alcalosis)
Time Frame: Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Presence of respiratory alcalosis define by by pH>7.45 and PaCO2 < 35 mmHg
|
Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventilator setting (Respiratory rate)
Time Frame: Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
|
Respiratory rate set by the doctor, these setting will be compared to the suggestion of the algorithm
|
Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
|
|
Ventilator setting (Tidal volume)
Time Frame: Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
|
Tidal volume set by the doctor, these setting will be compared to the suggestion of the algorithm
|
Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
|
|
Acid-base disorder (metabolic acidosis)
Time Frame: Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Presence of metabolic acidosis define by HCO3 < 20 mmol/L
|
Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
|
Acid-base disorder (metabolic alcalosis)
Time Frame: Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Presence of metabolic acidosis define by HCO3 > 28 mmol/L
|
Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
|
Optimal acid-base result
Time Frame: Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
Presence of optimal pH (7.35-7.45)
with optimal PCO2 (35-45 mmHg)
|
Up to 4 hours after admission to the coronary care unit - First blood gas sample
|
|
Mechanical ventilation duration
Time Frame: Up to 90 days
|
Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge
|
Up to 90 days
|
|
Vasopressor duration
Time Frame: Day 28
|
Duration of vasopressor or inotrop administration
|
Day 28
|
|
Hospital length of stay
Time Frame: Up to 90 days
|
Coronary unit admission through hospital discharge
|
Up to 90 days
|
|
Mortality
Time Frame: Day 28
|
Mortality at coronary unit
|
Day 28
|
|
Acute renal failure
Time Frame: Up to 90 days. Coronary unit stay - admission through discharge or until death if occured
|
Rate of acute renal failure during coronary unit length of stay.
Renal failure will be defined according to the usual criteria, i.e., an increase of >27 mmol/L creatinine in 48 hours or 1.5x over the baseline
|
Up to 90 days. Coronary unit stay - admission through discharge or until death if occured
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-4504
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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