- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07484828
Utvärdering av syra-bas-rubbningar och ventilationsinställningar vid kardiogen chock och efter hjärtstopp: Jämförelse med VentilO-algoritmen (VentilO CU)
Utvärdering av Syra-bas-rubbningar och Ventilationsinställningar vid Kardiogen Chock och Patienter efter Hjärtstopp: Jämförelse 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Francois Lellouche
- Telefonnummer: 3572 1-418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
Studieorter
-
-
Quebec
-
Québec, Quebec, Kanada, G1V4G5
- Rekrytering
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
Kontakt:
- Francois Lellouche Principal Investigator
- Telefonnummer: 3572 418-656-8711
- E-post: francois.lellouche@criucpq.ulaval.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
post cardiac arrest or cardiogenic shock
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: RETROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patient post hjärtstopp
|
Blood gases evaluation after initiation of mechanical ventilation |
|
Patient med kardiogen chock
|
Blood gases evaluation after initiation of mechanical ventilation |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acid-base disorder (respiratory acidosis)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ventilator setting (Respiratory rate)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Up to 90 days
|
Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge |
Up to 90 days
|
|
Vasopressor duration
Tidsram: Day 28
|
Duration of vasopressor or inotrop administration |
Day 28
|
|
Hospital length of stay
Tidsram: Up to 90 days
|
Coronary unit admission through hospital discharge |
Up to 90 days
|
|
Mortality
Tidsram: Day 28
|
Mortality at coronary unit |
Day 28
|
|
Acute renal failure
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-4504
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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