Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Phase 3

Recruiting

• Conditions: Respiratory Failure; Critical Illness
• Interventions: Drug: Noradrenaline

• Registration Number: NCT05014581
• Lead Sponsor: University of Turin, Italy

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-14
• Study First Posted: 2021-08-20
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-emptive vasopressor	Noradrenaline	Pre-emptive continuous infusion of norepinephrine during intubation

Primary Outcome Measures

Name	Time	Method
Number of patients with cardiovascular collapse	30 minutes from induction	Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest

Secondary Outcome Measures

Name	Time	Method
Change in SBP value from last value before induction to lowest value	30 minutes from induction	Drop of the systolic blood pressure from baseline value to the lowest value registered by 30 minutes from induction
Lowest value of SBP	30 minutes from induction	Lowest systolic blood pressure
Need for a rescue vasopressor	30 minutes from induction	Any unplanned administration of a vasopressor (either as bolus or continuous infusion)
Number of patients with MAP < 60 mmHg	30 minutes from induction	Mean arterial pressure \< 60 mmHg
Number of patients with severe hypertension	30 minutes from induction	Mean arterial pressure \> 120 mmHg
Number of patients with cardiac arrest	30 minutes from induction	Development of either a shockable or non shockable rhythm associated with cardiac arrest

Trial Locations

Locations (6)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milan, Italy

Policlinico di Milano; 🇮🇹 Milan, Italy

CHU de Nantes; 🇫🇷 Nantes, France

Galway University Hospitals; 🇮🇪 Galway, Ireland

University Hospital San Luigi Gonzaga; 🇮🇹 Orbassano, Turin, Italy