- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07484828
Evaluering av syre-base-forstyrrelser og ventilasjonsinnstillinger hos pasienter med kardiogent sjokk og etter hjertestans: Sammenligning med VentilO-algoritmen (VentilO CU)
Evaluering av syre-base-forstyrrelser og ventilasjonsinnstillinger hos pasienter med kardiogen sjokk og etter hjertestans: Sammenligning med VentilO-algoritmen
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Francois Lellouche
- Telefonnummer: 3572 1-418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
Studiesteder
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Rekruttering
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Ta kontakt med:
- Francois Lellouche Principal Investigator
- Telefonnummer: 3572 418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
post cardiac arrest or cardiogenic shock
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pasient etter hjertestans
|
Blood gases evaluation after initiation of mechanical ventilation |
|
Pasient med kardiogen sjokk
|
Blood gases evaluation after initiation of mechanical ventilation |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acid-base disorder (respiratory acidosis)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ventilator setting (Respiratory rate)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 90 days
|
Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge |
Up to 90 days
|
|
Vasopressor duration
Tidsramme: Day 28
|
Duration of vasopressor or inotrop administration |
Day 28
|
|
Hospital length of stay
Tidsramme: Up to 90 days
|
Coronary unit admission through hospital discharge |
Up to 90 days
|
|
Mortality
Tidsramme: Day 28
|
Mortality at coronary unit |
Day 28
|
|
Acute renal failure
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-4504
Plan for individuelle deltakerdata (IPD)
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