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NCT Number: NCT05014581

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Nantes, Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noradrenaline

Drug

Pre-emptive continuous infusion of noradrenaline during the peri-intubation period

Other names: Norepinephrine

Primary outcomes

  1. Number of patients with cardiovascular collapse

    Time frame: 30 minutes from induction

    Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest

Secondary outcomes

  1. Number of patients with cardiac arrest

    Time frame: 30 minutes from induction

    Development of either a shockable or non shockable rhythm associated with cardiac arrest

  2. Number of patients with MAP < 60 mmHg

    Time frame: 30 minutes from induction

    Mean arterial pressure < 60 mmHg

  3. Need for a rescue vasopressor

    Time frame: 30 minutes from induction

    Any unplanned administration of a vasopressor (either as bolus or continuous infusion)

  4. Change in SBP value from last value before induction to lowest value

    Time frame: 30 minutes from induction

    Drop of the systolic blood pressure from baseline value to the lowest value registered by 30 minutes from induction

  5. Lowest value of SBP

    Time frame: 30 minutes from induction

    Lowest systolic blood pressure

  6. Number of patients with severe hypertension

    Time frame: 30 minutes from induction

    Mean arterial pressure > 120 mmHg

Other outcomes

  1. Number of patients with cardiac arrhythmias

    Time frame: 30 minutes from induction

    Any ventricular or supraventricular arrhythmia

  2. Number of patients with bradycardia

    Time frame: 30 minutes from induction

    Heart rate < 60 beats per minute

  3. Signs of tissue/peripheral ischemia at noradrenaline infusion site

    Time frame: 24 hours

    Any sign of tissue/limb ischemia in case of peripheral vein infusion of noradrenaline

  4. Need for new start of renal replacement therapy

    Time frame: 28 days from intubation

    Need to start either continuous or intermittent renal replacement therapy

  5. Total amount of fluid administered (ml)

    Time frame: 30 minutes from induction

    Cumulative volume of fluids (ml)

  6. First pass intubation success

    Time frame: 30 minutes from induction

    Confirmed intubation after a single attempt of laryngoscopy

  7. Total amount of rescue vasopressors after induction

    Time frame: 30 minutes from induction

    Cumulative dose of any vasopressor administered either as a bolus or continuous infusion

  8. ICU-free days

    Time frame: 28 days from intubation

    Total number of days outside the ICU up to 28 days

  9. Ventilator-free days

    Time frame: 28 days from intubation

    Total number of days free from invasive mechanical ventilation

  10. Vasopressor-free days

    Time frame: 28 days from intubation

    Total number of days free from any vasopressor administration

  11. In-hospital mortality

    Time frame: 28 days from intubation

    Death during the hospital admission up to 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Vasamì

CONTACT

[email protected]

Vincenzo Russotto, MD

CONTACT

[email protected]

+393297893044

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

Registry information

Official study title

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

Acronym: PREVENTION

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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