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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05609357
Collaborator
(none)
20
Enrollment
1
Arm
4.8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Head-up Cardiopulmonary Resuscitation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research
Anticipated Study Start Date :
Nov 4, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Head-up Cardiopulmonary Resuscitation

Device: Head-up Cardiopulmonary Resuscitation
Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation

Outcome Measures

Primary Outcome Measures

  1. Number and portion of participants with serious or non-serious adverse event [Up to 1 day]

    e.g. event of fall, failure of intubation

Secondary Outcome Measures

  1. Number and portion of participants with repeated CPR [up to 1 day]

  2. Number and portion of participants with survival to emergency department discharge [up to 1 day]

  3. Number and portion of participants with sustained return of spontaneous circulation [Up to 1 day]

    sustained ROSC ≥ 20 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Wei-Ting Chen, National Taiwan University Hospital
  • Principal Investigator: Chien-Hua Huang, National Taiwan University Hospital
  • Principal Investigator: Min-Shan Tsai, National Taiwan University Hospital
  • Study Chair: Chih-Hsien Lin, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05609357
Other Study ID Numbers:
  • 202204040DIND
First Posted:
Nov 8, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
cardiac arrest
Head-up Cardiopulmonary Resuscitation
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Nov 8, 2022