Critical Illness, Respiratory Failure
Conditions
Keywords
tracheal intubation
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 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
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.
Interventions
DRUGNoradrenaline
Pre-emptive continuous infusion of noradrenaline during the peri-intubation period
Sponsors
Istituto Di Ricerche Farmacologiche Mario Negri
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cardiovascular collapse | 30 minutes from induction | Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cardiac arrest | 30 minutes from induction | Development of either a shockable or non shockable rhythm associated with cardiac arrest |
| Number of patients with MAP < 60 mmHg | 30 minutes from induction | Mean arterial pressure \< 60 mmHg |
| 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 of SBP | 30 minutes from induction | Lowest systolic blood pressure |
| Number of patients with severe hypertension | 30 minutes from induction | Mean arterial pressure \> 120 mmHg |
| Need for a rescue vasopressor | 30 minutes from induction | Any unplanned administration of a vasopressor (either as bolus or continuous infusion) |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU-free days | 28 days from intubation | Total number of days outside the ICU up to 28 days |
| Ventilator-free days | 28 days from intubation | Total number of days free from invasive mechanical ventilation |
| Number of patients with cardiac arrhythmias | 30 minutes from induction | Any ventricular or supraventricular arrhythmia |
| In-hospital mortality | 28 days from intubation | Death during the hospital admission up to 28 days |
| Vasopressor-free days | 28 days from intubation | Total number of days free from any vasopressor administration |
| Number of patients with bradycardia | 30 minutes from induction | Heart rate \< 60 beats per minute |
| Signs of tissue/peripheral ischemia at noradrenaline infusion site | 24 hours | Any sign of tissue/limb ischemia in case of peripheral vein infusion of noradrenaline |
| Need for new start of renal replacement therapy | 28 days from intubation | Need to start either continuous or intermittent renal replacement therapy |
| Total amount of fluid administered (ml) | 30 minutes from induction | Cumulative volume of fluids (ml) |
| First pass intubation success | 30 minutes from induction | Confirmed intubation after a single attempt of laryngoscopy |
| Total amount of rescue vasopressors after induction | 30 minutes from induction | Cumulative dose of any vasopressor administered either as a bolus or continuous infusion |
Countries
France, Ireland, Italy
Contacts
Primary ContactVincenzo Russotto, MD
Backup ContactAntonella Vasamì
Outcome results
None listed