Actively Recruiting
Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
Led by University of Turin, Italy · Updated on 2025-03-28
420
Participants Needed
6
Research Sites
86 weeks
Total Duration
On this page
Sponsors
U
University of Turin, Italy
Lead Sponsor
I
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is admitted or scheduled for admission to a participating study hospital
- Planned procedure is tracheal intubation with a provider expected to routinely perform intubation
- Critical illness requiring intubation for cardiorespiratory failure or neurological impairment
- Sedation planned with or without neuromuscular blockade
- Age 18 years or older
You will not qualify if you...
- No vasopressors or inotropes at the time of eligibility screening
- Mean arterial pressure less than 60 mmHg or greater than 120 mmHg at screening
- Urgency of intubation prevents safe study procedures
- Intubation during cardiopulmonary resuscitation of a patient in cardiac arrest
- Participation in another unapproved clinical trial
- Pregnant or suspected pregnancy
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU de Nantes
Nantes, France
Not Yet Recruiting
2
Galway University Hospitals
Galway, Ireland
Not Yet Recruiting
3
Humanitas Research Hospital
Rozzano, Milan, Italy
Actively Recruiting
4
University Hospital San Luigi Gonzaga
Orbassano, Turin, Italy, 10043
Not Yet Recruiting
5
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
6
Policlinico di Milano
Milan, Italy
Actively Recruiting
Research Team
V
Vincenzo Russotto, MD
CONTACT
A
Antonella Vasamì
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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