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

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest (OHCA) ACLS CPR Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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:

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

Primary outcomes

Mean tidal volume

Time frame: 15 minutes

Mean tidal volume

Secondary outcomes

Mean minute ventilation and end-tidal carbon dioxide

Time frame: 15 minutes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feier Song Song, MD

CONTACT

[email protected]

86-020-83827812

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study 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

Acronym: Bio-CPR

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 2, 2025
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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