- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07484828
Bewertung von Säure-Basen-Störungen und Beatmungseinstellungen bei Patienten mit kardiogenem Schock und nach Herzstillstand: Vergleich mit dem VentilO-Algorithmus (VentilO CU)
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Francois Lellouche
- Telefonnummer: 3572 1-418-656-8711
- E-Mail: francois.lellouche@criucpq.ulaval.ca
Studienorte
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-
Quebec
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Québec, Quebec, Kanada, G1V4G5
- Rekrutierung
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Kontakt:
- Francois Lellouche Principal Investigator
- Telefonnummer: 3572 418-656-8711
- E-Mail: francois.lellouche@criucpq.ulaval.ca
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
post cardiac arrest or cardiogenic shock
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: RETROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Patient nach Herzstillstand
|
Blood gases evaluation after initiation of mechanical ventilation |
|
Patient mit kardiogenem Schock
|
Blood gases evaluation after initiation of mechanical ventilation |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acid-base disorder (respiratory acidosis)
Zeitfenster: 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)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Ventilator setting (Respiratory rate)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 90 days
|
Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge |
Up to 90 days
|
|
Vasopressor duration
Zeitfenster: Day 28
|
Duration of vasopressor or inotrop administration |
Day 28
|
|
Hospital length of stay
Zeitfenster: Up to 90 days
|
Coronary unit admission through hospital discharge |
Up to 90 days
|
|
Mortality
Zeitfenster: Day 28
|
Mortality at coronary unit |
Day 28
|
|
Acute renal failure
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-4504
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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