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

NCT ID: NCT07258823

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bio-CPR experimental group

Bio-CPR ventilation mode

Group Type EXPERIMENTAL

CPR

Intervention Type 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

Traditional compression/ventilation mode group

Traditional compression/ventilation mode

Group Type ACTIVE_COMPARATOR

CPR

Intervention Type 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

Interventions

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CPR

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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lixin

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Feier Song Song, MD

Role: CONTACT

86-020-83827812

References

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Other Identifiers

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ChiCTR2400094466

Identifier Type: -

Identifier Source: org_study_id

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