PREVENTION: Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
Study Details
Study Description
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 to the goal of MAP 100 mmHg. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure within 30 minutes, ICU and in-hospital mortality.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 to reach the mean arterial pressure (MAP) goal of 100 mmHg 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 ICU mortality.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pre-emptive vasopressor Pre-emptive continuous infusion of norepinephrine during intubation |
Drug: Noradrenaline
Pre-emptive continuous infusion of noradrenaline during the peri-intubation period
Other Names:
|
| No Intervention: No vasopressor No pre-emptive administration of vasopressors |
Outcome Measures
Primary Outcome Measures
- Number of patients with cardiovascular collapse [30 minutes from induction]
Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest
Secondary Outcome Measures
- Number of patients with MAP < 60 mmHg [30 minutes from induction]
Mean arterial pressure < 60 mmHg
- Number of patients with cardiac arrest [30 minutes from induction]
Development of either a shockable or non shockable rhythm associated with cardiac arrest
- Lowest value of SBP [30 minutes from induction]
Lowest systolic blood pressure
- Number of patients with SBP < 65 mmHg [30 minutes from induction]
Systolic blood pressure < 65 mmHg
- Total volume (ml) of administered fluids [30 minutes from induction]
Total volume of fluids administered from induction to 30 minutes to maintain the hemodynamic target
- Number of patients with death within 30 minutes from induction [30 minutes from induction]
Cardiac arrest without return of spontaneous circulation and death
- 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 SpO2 % [30 minutes from induction]
Lowest peripheral oxygen saturation registered between induction and 30 minutes
- Number of patients with first pass intubation success [30 minutes from induction]
Confirmed successful intubation after a single laryngoscopy attempt
- Number of patients with first pass success without adverse events [30 minutes from induction]
Confirmed successful intubation with a single laryngoscopy attempt without peri-intubation cardiovascular collapse and severe hypoxemia
- Number of patients with hypoxemia [30 minutes from induction]
SpO2 < 90%
- Number of patients with severe hypoxemia [30 minutes from induction]
SpO2 < 80%
- Number of patients with need for new start of renal replacement therapy [28 days from intubation]
Development of acute renal failure with need of new start of renal replacement therapy
- ICU free days [28 days from intubation]
Days with a patient alive and without admission to an intensive care unit
- ICU mortality [28 days from intubation]
Death during the ICU stay
- Ventilator free days [28 days from intubation]
Days with a patient alive and free from mechanical ventilation support
- In-hospital mortality [28 days from intubation]
Death during the hospital stay
- Lowest SBP value in the 24 hours after intubation [24 hours from intubation]
Lowest systolic blood pressure
- Highest dose of vasopressor in the 24 hours after intubation [24 hours from intubation]
Highest dose of any vasopressor administered as a continuous infusion (mcg/Kg/min)
- Vasopressor-free days up to 28 days [28 days from intubation]
Days without any continuous infusion of vasopressors
- Lowest oxygen saturation in the 24 hours after intubation [24 hours from intubation]
Lowest peripheral oxygen saturation
- Highest fraction of inspired oxygen in the 24 hours after intubation [24 hours from intubation]
Highest fraction of inspired oxygen during invasive mechanical ventilation
- Highest PEEP value in the 24 hours after intubation [24 hours from intubation]
Highest value of positive end expiratory pressure (cmH2O) during invasive mechanical ventilation
- Fluid balance of the first 24 hours following intubation [24 hours from intubation]
Positive or negative fluid balance in milliliters
- Number of patients with severe hypertension [30 minutes from induction]
Systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 120 mmHg or higher
- Number of patients with cardiac arrhythmias [30 minutes from induction]
Occurrence of any supraventricular or ventricular arrhythmia
- Number of patients with bradycardia [30 minutes from induction]
Heart rate < 60 beats per minute
Eligibility Criteria
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:
-
Operator feels vasopressor support is absolutely indicated or contraindicated in the patient
-
Urgency of intubation precludes safe performance of study procedures
-
Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest
-
Pregnant or suspected pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nantes | Nantes | France | ||
| 2 | Galway University Hospitals | Galway | Ireland | ||
| 3 | University Hospital San Gerardo | Monza | Italy |
Sponsors and Collaborators
- Azienda Ospedaliera San Gerardo di Monza
Investigators
- Principal Investigator: Vincenzo Russotto, MD, University Hospital San Gerardo Monza, Italy
- Study Chair: John G Laffey, MD, University Hospital Galway, NUI Galway, Ireland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PREVENTION