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

ConditionsOut-of-hospital Cardiac Arrest (OHCA)Cardiac Arrest (CA)CPR ACLS

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorGuangdong Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

CPR
Procedure/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

Treatment groups

408 Participants

are divided into 2 treatment groups

Group A: Bio-CPR experimental groupExperimental treatment 1 intervention

Group B: Traditional compression/ventilation mode groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Mean tidal volume

Time frame

15 minutes

Secondary outcomes

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.

Time frame

15 minutes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: