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The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest

Primary Purpose

Cardiac Arrest

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Head-up Cardiopulmonary Resuscitation

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, Head-up Cardiopulmonary Resuscitation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-traumatic cardiac arrest Age ≥ 20 Exclusion Criteria: Trauma Age < 20 Pregnancy Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition) Disorder of cervical spine

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Head-up Cardiopulmonary Resuscitation

Arm Description

Outcomes

Primary Outcome Measures

Number and portion of participants with serious or non-serious adverse event

e.g. event of fall, failure of intubation

Secondary Outcome Measures

Number and portion of participants with repeated CPR

Number and portion of participants with survival to emergency department discharge

Number and portion of participants with sustained return of spontaneous circulation

sustained ROSC ≥ 20 minutes

Full Information

NCT ID

NCT05609357

First Posted

October 19, 2022

Last Updated

August 8, 2023

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05609357

Brief Title

The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest

Official Title

The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 4, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Head up CPR with impedance threshold device(ITD) and active compression-decompression (ACD) has been proved to improve both cerebral and coronary perfusion pressure during resuscitation in animal models. Increased rates of Spontaneous Circulation (ROSC) were also observed in cardiac arrest patients. The goal of this clinical trial is to learn about the feasibility and safety of Head-up Cardiopulmonary Resuscitation in patients with non-traumatic cardiac arrest. Participants will be received head-up CPR during resuscitation. The main question it aims to answer is if there is any adverse or unfavorable event during resuscitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

cardiac arrest, Head-up Cardiopulmonary Resuscitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Head-up Cardiopulmonary Resuscitation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Head-up Cardiopulmonary Resuscitation

Intervention Description

Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation

Primary Outcome Measure Information:

Title

Number and portion of participants with serious or non-serious adverse event

Description

e.g. event of fall, failure of intubation

Time Frame

Up to 1 day

Secondary Outcome Measure Information:

Title

Number and portion of participants with repeated CPR

Time Frame

up to 1 day

Title

Number and portion of participants with survival to emergency department discharge

Time Frame

up to 1 day

Title

Number and portion of participants with sustained return of spontaneous circulation

Description

sustained ROSC ≥ 20 minutes

Time Frame

Up to 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chih-Hsien Lin

Phone

+886972653698

47ienn@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-Ting Chen

Phone

+88623123456#26283

biochip52@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-Ting Chen

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chien-Hua Huang

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Min-Shan Tsai

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chih-Hsien Lin

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chih-Hsien Lin

47ienn@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest

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