Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 to the goal of MAP 100 mmHg. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure within 30 minutes, ICU and in-hospital mortality.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza
• Treatments: Norepinephrine

Criteria

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:

• Operator feels vasopressor support is absolutely indicated or contraindicated in the patient

• Urgency of intubation precludes safe performance of study procedures

• Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest

• Pregnant or suspected pregnancy