NCT05609357

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

October 19, 2022

Last Update Submit

August 8, 2023

Conditions

Keywords

cardiac arrestHead-up Cardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

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

    e.g. event of fall, failure of intubation

    Up to 1 day

Secondary Outcomes (3)

  • Number and portion of participants with repeated CPR

    up to 1 day

  • Number and portion of participants with survival to emergency department discharge

    up to 1 day

  • Number and portion of participants with sustained return of spontaneous circulation

    Up to 1 day

Study Arms (1)

Head-up Cardiopulmonary Resuscitation

EXPERIMENTAL
Device: Head-up Cardiopulmonary Resuscitation

Interventions

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

Head-up Cardiopulmonary Resuscitation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-traumatic cardiac arrest
  • Age ≥ 20

You may not qualify if:

  • Trauma
  • Age \< 20
  • Pregnancy
  • Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition)
  • Disorder of cervical spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Chih-Hsien Lin

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2022

First Posted

November 8, 2022

Study Start

November 4, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations