RecruitingPhase 3NCT05014581

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study


Sponsor

University of Turin, Italy

Enrollment

420 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DRUGNoradrenaline

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


Locations(6)

CHU de Nantes

Nantes, France

Galway University Hospitals

Galway, Ireland

Humanitas Research Hospital

Rozzano, Milan, Italy

University Hospital San Luigi Gonzaga

Orbassano, Turin, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Policlinico di Milano

Milan, Italy

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