Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
NCT05014581 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2025-03-28
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.
Conditions
- Critical Illness
- Respiratory Failure
Interventions
- DRUG
-
Noradrenaline
Pre-emptive continuous infusion of noradrenaline during the peri-intubation period
Sponsors & Collaborators
-
Istituto Di Ricerche Farmacologiche Mario Negri
collaborator OTHER -
University of Turin, Italy
lead OTHER
Principal Investigators
-
Vincenzo Russotto, MD · University Hospital San Luigi Gonzaga
-
John G Laffey, MD · University Hospital Galway, NUI Galway, Ireland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2026-03-31
- Completion
- 2026-04-30
Countries
- France
- Ireland
- Italy
Study Locations
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