Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Number of patients with cardiovascular collapse [Срок оценки: 30 minutes from induction]

Вторичные конечные точки (6)

• Number of patients with cardiac arrest [Срок оценки: 30 minutes from induction]
• Number of patients with MAP < 60 mmHg [Срок оценки: 30 minutes from induction]
• Need for a rescue vasopressor [Срок оценки: 30 minutes from induction]
• Change in SBP value from last value before induction to lowest value [Срок оценки: 30 minutes from induction]
• Lowest value of SBP [Срок оценки: 30 minutes from induction]
• Number of patients with severe hypertension [Срок оценки: 30 minutes from induction]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 4 центра

• Humanitas Research Hospital — Rozzano
• University Hospital San Luigi Gonzaga — Orbassano
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Policlinico di Milano — Milan

Франция · 1 центр

• CHU de Nantes — Nantes

Ирландия · 1 центр

• Galway University Hospitals — Galway

Публикации

• 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. PMID 33755076
• 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
• 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 controlle PMID 31585796

Идентификаторы

NCT: NCT05014581 · PREVENTION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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