Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

NCT ID: NCT05014581

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-04-30

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.

Conditions

Critical Illness; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-emptive vasopressor

Pre-emptive continuous infusion of norepinephrine during intubation

Group Type: EXPERIMENTAL

Noradrenaline

Intervention Type: DRUG

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

No vasopressor

No pre-emptive administration of vasopressors

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Noradrenaline

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

Intervention Type: DRUG

Other Intervention Names

Norepinephrine

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Di Ricerche Farmacologiche Mario Negri

OTHER

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Vincenzo Russotto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Russotto, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital San Luigi Gonzaga

John G Laffey, MD

Role: STUDY_CHAIR

University Hospital Galway, NUI Galway, Ireland

Locations

CHU de Nantes

Nantes, , France

Site Status: NOT_YET_RECRUITING

Galway University Hospitals

Galway, , Ireland

Site Status: NOT_YET_RECRUITING

Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status: RECRUITING

University Hospital San Luigi Gonzaga

Orbassano, Turin, Italy

Site Status: NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status: RECRUITING

Policlinico di Milano

Milan, , Italy

Site Status: RECRUITING

Countries

France; Ireland; Italy

Central Contacts

Vincenzo Russotto, MD

Role: CONTACT

vincenzo.russotto@unito.it

+393297893044

Antonella Vasamì

Role: CONTACT

antonella.vasami@marionegri.it

Facility Contacts

Jean Baptiste Lascarrou, MD, PhD

Role: primary

John G Laffey, MD

Role: primary

Alessandro Protti

Role: primary

Vincenzo Russotto, MD

Role: primary

vincenzo.russotto@unito.it

Pietro Caironi, MD

Role: backup

Thomas Langer

Role: primary

Giacomo Grasselli

Role: primary

References

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.

Reference Type: RESULT

PMID: 33755076 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31529354 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31585796 (View on PubMed)

Other Identifiers

PREVENTION

Identifier Type: -

Identifier Source: org_study_id