the Effectiveness of Continuous Compression-synchronous Ventilation (Bio-CPR)

Официальное название

Study on the Effectiveness of Continuous Compression-synchronous Ventilation (Bio-CPR) in the ACLS Stage of Cardiopulmonary Resuscitation (ACLS) Based on the Bionic Concept to Explore the Best Mechanical Ventilation Strategy

Обзор

Bio-CPR is an innovative new mechanical resuscitation model proposed by our research group. A multi-center RCT study was established to comprehensively evaluate the efficacy of this model and the current standard CPR protocol, verify its safety and efficacy, and provide high-quality clinical evidence support.

Вмешательства

• Процедура CPR
  ACLS/CPR (Bio-CPR Group vs. Traditional Resuscitation Group) This intervention targets adult patients with in-hospital or out-of-hospital cardiac arrest (CA) who require advanced resuscitation. All patients receive immediate basic life support (BLS) upon medical contact, followed by standardized advanced cardiac life support (ACLS) with uniform use of the integrated "CPR Machine E8 - Ventilator T7" system (distinguishing it from manual CPR or other device-based protocols). Randomization determi

Первичные конечные точки

• Mean tidal volume [Срок оценки: 15 minutes]

Вторичные конечные точки (1)

• Mean minute ventilation and end-tidal carbon dioxide [Срок оценки: 15 minutes]

Критерии участия

Критерии включения

• 18-65 years old; 2. Cardiac arrest with witnesses; 3. Onset - compression start time<5 minutes; 4. Initial ventricular fibrillation rhythm; 5. Endotracheal intubation and use of a mechanical chest CPR device; Patients with OHCA who meet the above conditions

Критерии исключения

• 1\. OHCA patients who are not suitable for mechanical compression ventilation; 2. The participant or his/her legally authorized representative (LAR) is unable or unwilling to provide written informed consent.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Andersen LW, Isbye D, Kjaergaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Lofgren B, Lauridsen KG, Solling C, Paelestik K, Kjaergaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Hoybye M, Sindberg B, Holmberg MJ, Granfeldt A. E PMID 34587236
• Greif R, Bray JE, Djarv T, Drennan IR, Liley HG, Ng KC, Cheng A, Douma MJ, Scholefield BR, Smyth M, Weiner G, Abelairas-Gomez C, Acworth J, Anderson N, Atkins DL, Berry DC, Bhanji F, Bottiger BW, Bradley RN, Breckwoldt J, Carlson JN, Cassan P, Chang WT, Charlton NP, Phil Chung S, Considine J, Cortegiani A, Costa-Nobre DT, Couper K, Couto TB, Dainty KN, Dassanayake V, Davis PG, Dawson JA, de Caen A PMID 39540293
• Berg KM, Soar J, Andersen LW, Bottiger BW, Cacciola S, Callaway CW, Couper K, Cronberg T, D'Arrigo S, Deakin CD, Donnino MW, Drennan IR, Granfeldt A, Hoedemaekers CWE, Holmberg MJ, Hsu CH, Kamps M, Musiol S, Nation KJ, Neumar RW, Nicholson T, O'Neil BJ, Otto Q, de Paiva EF, Parr MJA, Reynolds JC, Sandroni C, Scholefield BR, Skrifvars MB, Wang TL, Wetsch WA, Yeung J, Morley PT, Morrison LJ, Welsfor PMID 33084390
• Nichol G, Leroux B, Wang H, Callaway CW, Sopko G, Weisfeldt M, Stiell I, Morrison LJ, Aufderheide TP, Cheskes S, Christenson J, Kudenchuk P, Vaillancourt C, Rea TD, Idris AH, Colella R, Isaacs M, Straight R, Stephens S, Richardson J, Condle J, Schmicker RH, Egan D, May S, Ornato JP; ROC Investigators. Trial of Continuous or Interrupted Chest Compressions during CPR. N Engl J Med. 2015 Dec 3;373(23 PMID 26550795
• Zheng J, Lv C, Zheng W, Zhang G, Tan H, Ma Y, Zhu Y, Li C, Han X, Yan S, Pan C, Zhang J, Hou Y, Wang C, Bian Y, Liu R, Cheng K, Ma J, Zheng Z, Song R, Wang M, Gu J, McNally B, Ong MEH, Chen Y, Xu F; BASIC-OHCA Coordinators and Investigators. Incidence, process of care, and outcomes of out-of-hospital cardiac arrest in China: a prospective study of the BASIC-OHCA registry. Lancet Public Health. 202 PMID 37722403
• Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial PMID 33197396
• Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care PMID 33081529
• Schmidt H, Kjaergaard J, Hassager C, Molstrom S, Grand J, Borregaard B, Roelsgaard Obling LE, Veno S, Sarkisian L, Mamaev D, Jensen LO, Nyholm B, Hofsten DE, Josiassen J, Thomsen JH, Thune JJ, Lindholm MG, Stengaard Meyer MA, Winther-Jensen M, Sorensen M, Frydland M, Beske RP, Frikke-Schmidt R, Wiberg S, Boesgaard S, Lind Jorgensen V, Moller JE. Oxygen Targets in Comatose Survivors of Cardiac Arre PMID 36027567

Идентификаторы

NCT: NCT07258823 · ChiCTR2400094466

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗