Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation (PREVENTION)

University of Turin

Status and phase

Enrolling

Phase 3

Conditions

Respiratory Failure

Critical Illness

Treatments

Drug: Noradrenaline

Study type

Interventional

Funder types

Other

Identifiers

NCT05014581

PREVENTION

Details and patient eligibility

About

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.

Full description

PREVENTION trial is a pragmatic, multi-center, un-blinded, parallel group, randomized study comparing the pre-emptive use of noradrenaline to no-vasopressors during the peri-intubation period of adult critically ill patients. Investigators hypothesize that the pre-emptive administration of noradrenaline would mitigate the incidence and severity of peri-intubation cardiovascular collapse. The study will include adult (18 yrs or older) critically ill patients needing in-hospital intubation, excluding patients with absolute indication or contraindication to vasopressors. Patients will be randomized to receive either a continuous infusion of noradrenaline started at least 8 minutes before induction vs no vasopressors during the peri-intubation period. All co-interventions will be provided according to clinician's judgement. The primary outcome of the study will be a composite of MAP < 60 mmHg or cardiac arrest. Secondary outcomes will include lowest systolic blood pressure < 30 minutes from induction, change in systolic blood pressure from baseline to the lowest value within 30 minutes from induction and cardiac arrest.

Enrollment

420 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

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