ACLS, Cardiac Arrest (CA), CPR, Out-of-hospital Cardiac Arrest (OHCA)
Conditions
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.
Interventions
PROCEDURECPR
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
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean tidal volume | 15 minutes | Mean tidal volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean minute ventilation and end-tidal carbon dioxide | 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. |
Contacts
Primary ContactFeier Song Song, MD
Outcome results
None listed