Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

NCT05014581 | Recruiting Phase 3 DMC

• 1 other identifier: PREVENTION
• Study Type: interventional
• Target: 420
• Locations: 3 countries
• Sites: 6

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.

Conditions

Critical Illness; Respiratory Failure

Keywords

tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Number of patients with cardiovascular collapse

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

  30 minutes from induction

Secondary Outcomes (6)

• Number of patients with cardiac arrest

  30 minutes from induction

• Number of patients with MAP < 60 mmHg

  30 minutes from induction

• Need for a rescue vasopressor

  30 minutes from induction

• Change in SBP value from last value before induction to lowest value

  30 minutes from induction

• Lowest value of SBP

  30 minutes from induction

Other Outcomes (11)

• Number of patients with cardiac arrhythmias

  30 minutes from induction

• Number of patients with bradycardia

  30 minutes from induction

• Signs of tissue/peripheral ischemia at noradrenaline infusion site

  24 hours

Study Arms (2)

Pre-emptive vasopressor

EXPERIMENTAL

Pre-emptive continuous infusion of norepinephrine during intubation

Drug: Noradrenaline

No vasopressor

NO INTERVENTION

No pre-emptive administration of vasopressors

Interventions

Noradrenaline DRUG

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

Also known as: Norepinephrine

Pre-emptive vasopressor

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (6)

CHU de Nantes

Nantes, France

NOT YET RECRUITING

Galway University Hospitals

Galway, Ireland

NOT YET RECRUITING

Humanitas Research Hospital

Rozzano, Milan, Italy

RECRUITING

University Hospital San Luigi Gonzaga

Orbassano, Turin, 10043, Italy

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

RECRUITING

Policlinico di Milano

Milan, Italy

RECRUITING

Related Publications (3)

• Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.

  PMID: 33755076 RESULT

• Russotto V, Myatra SN, Laffey JG. What's new in airway management of the critically ill. Intensive Care Med. 2019 Nov;45(11):1615-1618. doi: 10.1007/s00134-019-05757-0. Epub 2019 Sep 16. No abstract available.

  PMID: 31529354 RESULT

• Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

  PMID: 31585796 RESULT

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Vincenzo Russotto, MD

  University Hospital San Luigi Gonzaga

  PRINCIPAL INVESTIGATOR

• John G Laffey, MD

  University Hospital Galway, NUI Galway, Ireland

  STUDY CHAIR

Central Study Contacts

Vincenzo Russotto, MD

CONTACT

+393297893044; vincenzo.russotto@unito.it

Antonella Vasamì

CONTACT

antonella.vasami@marionegri.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 20, 2021
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

IE (1); IT (4); FR (1)