Mode of Ventilation During Critical Illness at Multiple Centers

Обзор

The goal of this clinical trial is to learn whether the choice of ventilator mode for patients on breathing machines in the intensive care unit affects their survival and recovery. To do this, researchers will assign the entire participating intensive care unit to one of the three available ventilator modes, alternating which mode is assigned in random sequence every 2 months. The main question it aims to answer is: Does the choice between volume control, pressure control, and adaptive pressure control affect the number of days that patients are alive and free of the breathing machine?

Подробное описание

The MODEM trial is a cluster-randomized, cluster-crossover clinical trial comparing the effectiveness of three ventilator modes (volume control vs pressure control vs adaptive pressure control) for mechanical ventilation of critically ill adults at multiple centers. A total of 4,785 critically ill adults receiving invasive mechanical ventilation in intensive care units will be enrolled and included in the primary analysis. Each study unit will be assigned to a ventilator mode and will switch between modes every 2 months in an order determined by randomization. Enrolled patients will be assigned to receive volume control, pressure control, or adaptive pressure control according to the mode assigned to the unit at the time they were enrolled. The primary outcome will be ventilator-free days in the first 28 days, and the secondary outcome will be all-cause, 28-day in-hospital mortality.

Вмешательства

• Другое Volume control
  Volume control mode for invasive mechanical ventilation
• Другое Pressure control
  Pressure control mode for invasive mechanical ventilation
• Другое Adaptive pressure control
  Adaptive pressure control for invasive mechanical ventilation

Первичные конечные точки

• Ventilator-free days in the first 28 days [Срок оценки: From enrollment to 28 days after enrollment]

Вторичные конечные точки (1)

• All-cause, 28-day, in-hospital mortality [Срок оценки: From enrollment to 28 days after enrollment]

Критерии участия

Критерии включения

• Patient is receiving mechanical ventilation through an endotracheal tube or tracheostomy
• Patient is physically located in a participating adult ICU

Критерии исключения

• Patient is known to be less than 18 years old
• Patient is known to be a prisoner
• Patient is known to have been receiving invasive mechanical ventilation at place of residence prior to hospital admission
• Patient is receiving extracorporeal membrane oxygenation at the time when inclusion criteria are first met

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Rush University Medical Center — Chicago
• The Johns Hopkins Hospital — Baltimore
• Wake Forest University Health Sciences — Winston-Salem
• Vanderbilt University Medical Center — Nashville

Публикации

• Rappaport SH, Shpiner R, Yoshihara G, Wright J, Chang P, Abraham E. Randomized, prospective trial of pressure-limited versus volume-controlled ventilation in severe respiratory failure. Crit Care Med. 1994 Jan;22(1):22-32. doi: 10.1097/00003246-199401000-00009. PMID 8124968
• Esteban A, Alia I, Gordo F, de Pablo R, Suarez J, Gonzalez G, Blanco J. Prospective randomized trial comparing pressure-controlled ventilation and volume-controlled ventilation in ARDS. For the Spanish Lung Failure Collaborative Group. Chest. 2000 Jun;117(6):1690-6. doi: 10.1378/chest.117.6.1690. PMID 10858404
• Rittayamai N, Katsios CM, Beloncle F, Friedrich JO, Mancebo J, Brochard L. Pressure-Controlled vs Volume-Controlled Ventilation in Acute Respiratory Failure: A Physiology-Based Narrative and Systematic Review. Chest. 2015 Aug;148(2):340-355. doi: 10.1378/chest.14-3169. PMID 25927671
• Chatburn RL, El-Khatib M, Mireles-Cabodevila E. A taxonomy for mechanical ventilation: 10 fundamental maxims. Respir Care. 2014 Nov;59(11):1747-63. doi: 10.4187/respcare.03057. Epub 2014 Aug 12. PMID 25118309
• Telias I, Madorno M, Pham T, Coudroy R, Mellado Artigas R, Baedorf-Kassis E, Chen CW, Spadaro S, Chiumello D, Beitler J, Kondili E, Tiribelli N, Fredes S, Becher T, Dres M, Liu K, Terzi N, Guerin C, Mauri T, Roca O, Mancebo J, Rodriguez N, Arnal JM, Goligher EC, Diehl JL, Jochmans S, Beloncle F, Rittayamai N, Mojoli F, Heunks L, de Vries H, Zhou JX, Guervilly C, Brochard L; BEARDS and PLUG Investi PMID 40700741
• Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Day PMID 40189043

Идентификаторы

NCT: NCT07313956 · 250596 · K23HL175246

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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