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
Sponsors and collaborators
University of Turin, Italy
Lead sponsor
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborator