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

NCT07258823 | Not Yet Recruiting

• 1 other identifier: ChiCTR2400094466
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Out-of-hospital Cardiac Arrest (OHCA); Cardiac Arrest (CA); CPR; ACLS

Outcome Measures

Primary Outcomes (1)

• Mean tidal volume

  Mean tidal volume

  15 minutes

Secondary Outcomes (1)

• Mean minute ventilation and end-tidal carbon dioxide

  15 minutes

Study Arms (2)

Bio-CPR experimental group

EXPERIMENTAL

Bio-CPR ventilation mode

Procedure: CPR

Traditional compression/ventilation mode group

ACTIVE COMPARATOR

Traditional compression/ventilation mode

Procedure: CPR

Interventions

CPR PROCEDURE

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 determines two subgroups with distinct ventilation and compression-coordination settings, as detailed below: 1\. Core Uniform Foundation (Applicable to Both Groups) Chest Compression Mode: Continuous compression mode is activated on the CPR Machine E8, eliminating variability from manual compression rate/depth and ensuring consistent compression quality. Airway \& Vascular Access: Advanced airway (e.g., endotracheal intubation) is established as soon as possible post-BLS initiation; peripheral or central

Bio-CPR experimental group; Traditional compression/ventilation mode group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Related Publications (15)

• Kamler M, Lehr HA, Barker JH, Saetzler RK, Galla TJ, Messmer K. Impact of ischemia on tissue oxygenation and wound healing: intravital microscopic studies on the hairless mouse ear model. Eur Surg Res. 1993 Jan-Feb;25(1):30-7. doi: 10.1159/000129254.

  PMID: 8482303 RESULT

• 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 AR, Deakin CD, Debaty G, Del Castillo J, Dewan M, Dicker B, Djakow J, Donoghue AJ, Eastwood K, El-Naggar W, Escalante-Kanashiro R, Fabres J, Farquharson B, Fawke J, de Almeida MF, Fernando SM, Finan E, Finn J, Flores GE, Foglia EE, Folke F, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hansen CM, Hatanaka T, Hirsch KG, Holmberg MJ, Hooper S, Hoover AV, Hsieh MJ, Ikeyama T, Isayama T, Johnson NJ, Josephsen J, Katheria A, Kawakami MD, Kleinman M, Kloeck D, Ko YC, Kudenchuk P, Kule A, Kurosawa H, Laermans J, Lagina A, Lauridsen KG, Lavonas EJ, Lee HC, Han Lim S, Lin Y, Lockey AS, Lopez-Herce J, Lukas G, Macneil F, Maconochie IK, Madar J, Martinez-Mejas A, Masterson S, Matsuyama T, Mausling R, McKinlay CJD, Meyran D, Montgomery W, Morley PT, Morrison LJ, Moskowitz AL, Myburgh M, Nabecker S, Nadkarni V, Nakwa F, Nation KJ, Nehme Z, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall G, Ohshimo S, Olasveengen T, Olaussen A, Ong G, Orkin A, Parr MJ, Perkins GD, Pocock H, Rabi Y, Raffay V, Raitt J, Raymond T, Ristagno G, Rodriguez-Nunez A, Rossano J, Rudiger M, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer G, Schnaubelt S, Seidler AL, Semeraro F, Singletary EM, Skrifvars MB, Smith CM, Soar J, Solevag AL, Soll R, Stassen W, Sugiura T, Thilakasiri K, Tijssen J, Tiwari LK, Topjian A, Trevisanuto D, Vaillancourt C, Welsford M, Wyckoff MH, Yang CW, Yeung J, Zelop CM, Zideman DA, Nolan JP, Berg KM. 2024 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Circulation. 2024 Dec 10;150(24):e580-e687. doi: 10.1161/CIR.0000000000001288. Epub 2024 Nov 14.

  PMID: 39540293 RESULT

• 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, Welsford M, Hazinski MF, Nolan JP; Adult Advanced Life Support Collaborators. Adult Advanced Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S92-S139. doi: 10.1161/CIR.0000000000000893. Epub 2020 Oct 21.

  PMID: 33084390 RESULT

• 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):2203-14. doi: 10.1056/NEJMoa1509139. Epub 2015 Nov 9.

  PMID: 26550795 RESULT

• 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. 2023 Dec;8(12):e923-e932. doi: 10.1016/S2468-2667(23)00173-1. Epub 2023 Sep 16.

  PMID: 37722403 RESULT

• Nichols JH, Howard C, Loman K, Miller C, Nyberg D, Chan DW. Laboratory and bedside evaluation of portable glucose meters. Am J Clin Pathol. 1995 Feb;103(2):244-51. doi: 10.1093/ajcp/103.2.244.

  PMID: 7856571 RESULT

• 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. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.

  PMID: 33081529 RESULT

• 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 Arrest. N Engl J Med. 2022 Oct 20;387(16):1467-1476. doi: 10.1056/NEJMoa2208686. Epub 2022 Aug 27.

  PMID: 36027567 RESULT

• Fuest K, Dorfhuber F, Lorenz M, von Dincklage F, Morgeli R, Kuhn KF, Jungwirth B, Kanz KG, Blobner M, Schaller SJ. Comparison of volume-controlled, pressure-controlled, and chest compression-induced ventilation during cardiopulmonary resuscitation with an automated mechanical chest compression device: A randomized clinical pilot study. Resuscitation. 2021 Sep;166:85-92. doi: 10.1016/j.resuscitation.2021.07.010. Epub 2021 Jul 22.

  PMID: 34302927 RESULT

• van Eijk JA, Doeleman LC, Loer SA, Koster RW, van Schuppen H, Schober P. Ventilation during cardiopulmonary resuscitation: A narrative review. Resuscitation. 2024 Oct;203:110366. doi: 10.1016/j.resuscitation.2024.110366. Epub 2024 Aug 23.

  PMID: 39181499 RESULT

• Tang Y, Sun M, Zhu A. Outcome of cardiopulmonary resuscitation with different ventilation modes in adults: A meta-analysis. Am J Emerg Med. 2022 Jul;57:60-69. doi: 10.1016/j.ajem.2022.04.027. Epub 2022 Apr 27.

  PMID: 35525159 RESULT

• Richman CM, Makii MM, Weiser PA, Herbst AL. The effect of lithium carbonate on chemotherapy-induced neutropenia and thrombocytopenia. Am J Hematol. 1984 May;16(4):313-23. doi: 10.1002/ajh.2830160402.

  PMID: 6426295 RESULT

• Zussman L, Zussman S, Sunley R, Bjornson E. Sexual response after hysterectomy-oophorectomy: recent studies and reconsideration of psychogenesis. Am J Obstet Gynecol. 1981 Aug 1;140(7):725-9. doi: 10.1016/0002-9378(81)90730-4.

  PMID: 7196155 RESULT

• Suverein MM, Delnoij TSR, Lorusso R, Brandon Bravo Bruinsma GJ, Otterspoor L, Elzo Kraemer CV, Vlaar APJ, van der Heijden JJ, Scholten E, den Uil C, Jansen T, van den Bogaard B, Kuijpers M, Lam KY, Montero Cabezas JM, Driessen AHG, Rittersma SZH, Heijnen BG, Dos Reis Miranda D, Bleeker G, de Metz J, Hermanides RS, Lopez Matta J, Eberl S, Donker DW, van Thiel RJ, Akin S, van Meer O, Henriques J, Bokhoven KC, Mandigers L, Bunge JJH, Bol ME, Winkens B, Essers B, Weerwind PW, Maessen JG, van de Poll MCG. Early Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest. N Engl J Med. 2023 Jan 26;388(4):299-309. doi: 10.1056/NEJMoa2204511.

  PMID: 36720132 RESULT

• Robinson H. Make phosphorus education hit home! J Ren Nutr. 1998 Jan;8(1):46-7. doi: 10.1016/s1051-2276(98)90038-3. No abstract available.

  PMID: 9724830 RESULT

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics

Central Study Contacts

Feier Song Song, MD

CONTACT

86-020-83827812; feiersong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share