The Feasibility and Safety of Head-up Cardiopulmonary Res... | NCT05609357

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

NCT05609357

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 9, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cardiac Arrest

Interventions

Head-up Cardiopulmonary Resuscitation

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Nov 3, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2023

Last Update Posted Date

Aug 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Head-up Cardiopulmonary Resuscitation	Experimental		Device: Head-up Cardiopulmonary Resuscitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head-up Cardiopulmonary Resuscitation	Device	Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation	Head-up Cardiopulmonary Resuscitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chih-Hsien Lin	Contact	+886972653698		47ienn@gmail.com
Wei-Ting Chen	Contact	+88623123456#26283		biochip52@hotmail.com

Overall Officials

Name	Affiliation	Role
Wei-Ting Chen	National Taiwan University Hospital	Principal Investigator
Chien-Hua Huang	National Taiwan University Hospital	Principal Investigator
Min-Shan Tsai

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided