Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Respiratory Failure

Intervention / Treatment
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* Drug: Noradrenaline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-emptive vasopressor<br>Pre-emptive continuous infusion of norepinephrine during intubation | Drug: Noradrenaline<br>* Pre-emptive continuous infusion of noradrenaline during the peri-intubation period<br>* Other names: Norepinephrine;|
| No Intervention: No vasopressor<br>No pre-emptive administration of vasopressors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cardiovascular collapse | Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest | 30 minutes from induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with cardiac arrest | Development of either a shockable or non shockable rhythm associated with cardiac arrest | 30 minutes from induction | 
| Number of patients with MAP < 60 mmHg | Mean arterial pressure < 60 mmHg | 30 minutes from induction | 
| Need for a rescue vasopressor | Any unplanned administration of a vasopressor (either as bolus or continuous infusion) | 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 | 30 minutes from induction | 
| Lowest value of SBP | Lowest systolic blood pressure | 30 minutes from induction | 
| Number of patients with severe hypertension | Mean arterial pressure > 120 mmHg | 30 minutes from induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheal intubation