Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation (PREVENTION)

March 24, 2025 updated by: Vincenzo Russotto, University of Turin, Italy

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nantes, France
        • Not yet recruiting
        • CHU de Nantes
        • Contact:
          • Jean Baptiste Lascarrou, MD, PhD
  • Ireland
      • Galway, Ireland
        • Not yet recruiting
        • Galway University Hospitals
        • Contact:
          • John G Laffey, MD
  • Italy
      • Milan, Italy
        • Recruiting
        • Policlinico di Milano
        • Contact:
          • Giacomo Grasselli
      • Milan, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Thomas Langer
    • Milan
      • Rozzano, Milan, Italy
        • Recruiting
        • Humanitas Research Hospital
        • Contact:
          • Alessandro Protti
    • Turin
      • Orbassano, Turin, Italy, 10043
        • Not yet recruiting
        • University Hospital San Luigi Gonzaga
        • Contact:
        • Contact:
          • Pietro Caironi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Norepinephrine
No Intervention: No vasopressor
No pre-emptive administration of vasopressors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with cardiovascular collapse
Time Frame: 30 minutes from induction
Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest
30 minutes from induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with MAP < 60 mmHg
Time Frame: 30 minutes from induction
Mean arterial pressure < 60 mmHg
30 minutes from induction
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
30 minutes from induction
Lowest value of SBP
Time Frame: 30 minutes from induction
Lowest systolic blood pressure
30 minutes from induction
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
30 minutes from induction
Need for a rescue vasopressor
Time Frame: 30 minutes from induction
Any unplanned administration of a vasopressor (either as bolus or continuous infusion)
30 minutes from induction
Number of patients with severe hypertension
Time Frame: 30 minutes from induction
Mean arterial pressure > 120 mmHg
30 minutes from induction

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with bradycardia
Time Frame: 30 minutes from induction
Heart rate < 60 beats per minute
30 minutes from induction
Number of patients with cardiac arrhythmias
Time Frame: 30 minutes from induction
Any ventricular or supraventricular arrhythmia
30 minutes from induction
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
24 hours
Need for new start of renal replacement therapy
Time Frame: 28 days from intubation
Need to start either continuous or intermittent renal replacement therapy
28 days from intubation
Total amount of fluid administered (ml)
Time Frame: 30 minutes from induction
Cumulative volume of fluids (ml)
30 minutes from induction
First pass intubation success
Time Frame: 30 minutes from induction
Confirmed intubation after a single attempt of laryngoscopy
30 minutes from induction
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
30 minutes from induction
ICU-free days
Time Frame: 28 days from intubation
Total number of days outside the ICU up to 28 days
28 days from intubation
Ventilator-free days
Time Frame: 28 days from intubation
Total number of days free from invasive mechanical ventilation
28 days from intubation
Vasopressor-free days
Time Frame: 28 days from intubation
Total number of days free from any vasopressor administration
28 days from intubation
In-hospital mortality
Time Frame: 28 days from intubation
Death during the hospital admission up to 28 days
28 days from intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turin, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto Di Ricerche Farmacologiche Mario Negri

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: John G Laffey, MD, University Hospital Galway, NUI Galway, Ireland
  • Principal Investigator: Vincenzo Russotto, MD, University Hospital San Luigi Gonzaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREVENTION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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