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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Pre-emptive continuous infusion of noradrenaline during the peri-intubation period
CHU de Nantes
Nantes, France
NOT_YET_RECRUITINGGalway University Hospitals
Galway, Ireland
NOT_YET_RECRUITINGHumanitas Research Hospital
Rozzano, Milan, Italy
RECRUITINGUniversity Hospital San Luigi Gonzaga
Orbassano, Turin, Italy
NOT_YET_RECRUITINGASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
RECRUITINGPoliclinico di Milano
Milan, Italy
RECRUITINGNumber of patients with cardiovascular collapse
Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest
Time frame: 30 minutes from induction
Number of patients with cardiac arrest
Development of either a shockable or non shockable rhythm associated with cardiac arrest
Time frame: 30 minutes from induction
Number of patients with MAP < 60 mmHg
Mean arterial pressure \< 60 mmHg
Time frame: 30 minutes from induction
Need for a rescue vasopressor
Any unplanned administration of a vasopressor (either as bolus or continuous infusion)
Time frame: 30 minutes from induction
Change in SBP value from last value before induction to lowest value
Drop of the systolic blood pressure from baseline value to the lowest value registered by 30 minutes from induction
Time frame: 30 minutes from induction
Lowest value of SBP
Lowest systolic blood pressure
Time frame: 30 minutes from induction
Number of patients with severe hypertension
Mean arterial pressure \> 120 mmHg
Time frame: 30 minutes from induction
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