- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07484828
Evaluatie van zuur-base-stoornissen en beademingsinstellingen bij patiënten met cardiogene shock en na een hartstilstand: vergelijking met het VentilO-algoritme (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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Francois Lellouche
- Telefoonnummer: 3572 1-418-656-8711
- E-mail: francois.lellouche@criucpq.ulaval.ca
Studie Locaties
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Werving
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Contact:
- Francois Lellouche Principal Investigator
- Telefoonnummer: 3572 418-656-8711
- E-mail: francois.lellouche@criucpq.ulaval.ca
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
post cardiac arrest or cardiogenic shock
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Patiënt na hartstilstand
|
Blood gases evaluation after initiation of mechanical ventilation |
|
Patiënt met cardiogene shock
|
Blood gases evaluation after initiation of mechanical ventilation |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acid-base disorder (respiratory acidosis)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Ventilator setting (Respiratory rate)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 90 days
|
Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge |
Up to 90 days
|
|
Vasopressor duration
Tijdsspanne: Day 28
|
Duration of vasopressor or inotrop administration |
Day 28
|
|
Hospital length of stay
Tijdsspanne: Up to 90 days
|
Coronary unit admission through hospital discharge |
Up to 90 days
|
|
Mortality
Tijdsspanne: Day 28
|
Mortality at coronary unit |
Day 28
|
|
Acute renal failure
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-4504
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .