Using noradrenaline to prevent cardiovascular collapse during tracheal intubation

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

This study is testing if giving critically ill adults noradrenaline before tracheal intubation can help prevent serious drops in blood pressure and heart problems during the procedure.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Turin, Italy (Academic / other)
• Locations: 6 sites (Nantes and 5 other locations)
• Trial ID: NCT05014581 on ClinicalTrials.gov

What this trial studies

The PREVENTION trial aims to evaluate the effectiveness of pre-emptive noradrenaline administration in preventing cardiovascular collapse during tracheal intubation in critically ill adults. This multi-center, randomized study will compare outcomes between patients receiving a continuous infusion of noradrenaline before intubation and those receiving no vasopressors. The primary outcome will focus on the incidence of cardiovascular collapse, while secondary outcomes will assess blood pressure changes and cardiac arrest rates within 30 minutes post-intubation. Eligible participants include adults requiring intubation due to critical illness, with specific exclusion criteria for those with contraindications to vasopressors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are critically ill and require tracheal intubation.

Not a fit: Patients with contraindications to vasopressor use or those in immediate need of intubation during resuscitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cardiovascular collapse during intubation in critically ill patients.

How similar studies have performed: Previous studies have explored vasopressor use in critical care settings, but this specific approach to peri-intubation management is relatively novel.

Eligibility 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:

* 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

Where this trial is running

Nantes and 5 other locations

• CHU de Nantes — Nantes, France (Not_yet_recruiting)
• Galway University Hospitals — Galway, Ireland (Not_yet_recruiting)
• Humanitas Research Hospital — Rozzano, Milan, Italy (Recruiting)
• University Hospital San Luigi Gonzaga — Orbassano, Turin, Italy (Not_yet_recruiting)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (Recruiting)
• Policlinico di Milano — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Vincenzo Russotto, MD — University Hospital San Luigi Gonzaga
• Study coordinator: Vincenzo Russotto, MD

Conditions Critical Illness; Respiratory Failure; tracheal intubation