NCT05014581

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Critical Illness
• Respiratory Failure

Interventions

Type	Name	Description
DRUG	Noradrenaline	Pre-emptive continuous infusion of noradrenaline during the peri-intubation period

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2021-08-20
• Last updated: 2025-03-28

Locations

6 sites across 3 countries: France, Ireland, Italy