Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Turin, Italy

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Noradrenaline

Treatment groups

420 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Turin, Italy

Lead sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborator