AzTrials
AzTrials

Out-of-hospital Cardiac Arrest (OHCA)Bio-CPRNCT07258823

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

A study testing CPR in people with Out-of-hospital Cardiac Arrest (OHCA) and Cardiac Arrest (CA), run by Guangdong Provincial People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CPR
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Feier Song Song, MD contact

86-020-83827812

feiersong@126.com

About this study

Official title: 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

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.

Being tested
CPR
Medical subject headings
Out-of-Hospital Cardiac Arrest, Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPRProcedure or surgery

    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

Study groups in NCT07258823
Study groupRoleWhat they receive
Bio-CPR experimental groupExperimentalBio-CPR ventilation mode
Receives: Procedure: CPR
Traditional compression/ventilation mode groupActive comparatorTraditional compression/ventilation mode
Receives: Procedure: CPR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean tidal volume

    Mean tidal volume

    Measured: 15 minutes

Secondary outcomes (1)
  1. Mean minute ventilation and end-tidal carbon dioxide

    Ventilation monitoring: EtCO2, dynamic monitoring of ventilator mechanical parameters, PEEPi+P0.1, tidal volume and minute ventilation volume were selected as the quality index of ventilation, and end-expiratory carbon dioxide was selected as the quality index of gas exchange. These values are collected by the ventilator software.

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258823
Sponsor's protocol ID
ChiCTR2400094466
Acronym
Bio-CPR
Status last verified
Nov 2025
First submitted
21 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628.

    PubMed 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 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.

    PubMed 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, 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.

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

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

    PubMed 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. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.

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

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

    PubMed 36027567
  • 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.

    PubMed 34302927
  • 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.

    PubMed 39181499
  • 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.

    PubMed 35525159
  • Hope Kilgannon J, Hunter BR, Puskarich MA, Shea L, Fuller BM, Jones C, Donnino M, Kline JA, Jones AE, Shapiro NI, Abella BS, Trzeciak S, Roberts BW. Partial pressure of arterial carbon dioxide after resuscitation from cardiac arrest and neurological outcome: A prospective multi-center protocol-directed cohort study. Resuscitation. 2019 Feb;135:212-220. doi: 10.1016/j.resuscitation.2018.11.015. Epub 2018 Nov 16.

    PubMed 30452939
  • Kim JW, Park SO, Lee KR, Hong DY, Baek KJ. Efficacy of Amflow(R), a Real-Time-Portable Feedback Device for Delivering Appropriate Ventilation in Critically Ill Patients: A Randomised, Controlled, Cross-Over Simulation Study. Emerg Med Int. 2020 Apr 24;2020:5296519. doi: 10.1155/2020/5296519. eCollection 2020.

    PubMed 32377436
  • 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.

    PubMed 36720132
  • Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.

    PubMed 36278971

Questions about this trial

What is this clinical trial studying?

A study testing CPR in people with Out-of-hospital Cardiac Arrest (OHCA) and Cardiac Arrest (CA), run by Guangdong Provincial People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Feier Song Song, MD (86-020-83827812, feiersong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean tidal volume (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258823, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in