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Clinical Trials in France / NCT05014581
Recruiting Phase 3

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

NCT05014581 · tracked via the Priya Life Science France tracker
Sponsor
University of Turin, Italy
Phase
Phase 3
Started
2024-08-01
Last updated
2025-03-28

Condition(s) studied

Critical IllnessRespiratory Failure

Investigational drug(s) / intervention(s)

Noradrenaline →

Noradrenaline: Pre-emptive continuous infusion of noradrenaline during the peri-intubation period

Study summary

Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Patient is admitted or scheduled for admission to a participating study hospital * Planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit * Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment) * Administration of sedation (with or without neuromuscular blockade) is planned * Age 18 years or older Exclusion Criteria: * No vasopressors/inotropes at the moment of screening for eligibility * MAP \< 60 mmHg or \> 120 mmHg at the moment of screening for eligibility * Urgency of intubation precludes safe performance of study procedures * Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest * Enrolled in another clinical trial that is unapproved for co-enrollment * Pregnant or suspected pregnancy

Primary outcome measure(s)

  • Number of patients with cardiovascular collapse — 30 minutes from induction
    Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest

Trial sites (6)

FacilityCityRegionStatus
CHU de Nantes Nantes France Not Yet Recruiting
Galway University Hospitals Galway Ireland Not Yet Recruiting
Humanitas Research Hospital Rozzano Milan Recruiting
University Hospital San Luigi Gonzaga Orbassano Turin Not Yet Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting
Policlinico di Milano Milan Italy Recruiting

More University of Turin, Italy trials in France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05014581 on ClinicalTrials.gov ↗ ← All trials in France