Cardiac ArrestNCT05609357
The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest
A study testing Head-up Cardiopulmonary Resuscitation in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Head-up Cardiopulmonary Resuscitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-traumatic cardiac arrest
- Age ≥ 20
Who cannot join
- Trauma
- Age < 20
- Pregnancy
- Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition)
- Disorder of cervical spine
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chih-Hsien Lin, 47ienn@gmail.com
About this study
Official title: The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research
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.
- Conditions
- Cardiac Arrest
- Being tested
- Head-up Cardiopulmonary Resuscitation
- Keywords
- cardiac arrest, Head-up Cardiopulmonary Resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-up Cardiopulmonary ResuscitationDevice
Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Head-up Cardiopulmonary Resuscitation | Experimental | Not described Receives: Device: Head-up Cardiopulmonary Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and portion of participants with serious or non-serious adverse event
e.g. event of fall, failure of intubation
Measured: Up to 1 day
Secondary outcomes (3)
Number and portion of participants with repeated CPR
Measured: up to 1 day
Number and portion of participants with survival to emergency department discharge
Measured: up to 1 day
Number and portion of participants with sustained return of spontaneous circulation
sustained ROSC ≥ 20 minutes
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start4 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Ting Chen, Principal investigator, National Taiwan University HospitalChien-Hua Huang, Principal investigator, National Taiwan University HospitalMin-Shan Tsai, Principal investigator, National Taiwan University HospitalChih-Hsien Lin, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609357
- Sponsor's protocol ID
- 202204040DIND
- Status last verified
- Aug 2023
- First submitted
- 19 Oct 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research
- ClinicalTrials.gov ID
- NCT05609357
- Acronym / sponsor ID
- 202204040DIND
- Conditions
- Cardiac Arrest
- Keywords
- cardiac arrest, Head-up Cardiopulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head-up Cardiopulmonary Resuscitation | Experimental | Device: Head-up Cardiopulmonary Resuscitation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-traumatic cardiac arrest
- Age ≥ 20
Key exclusion criteria (5 listed)
- Trauma
- Age < 20
- Pregnancy
- Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition)
- Disorder of cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-up Cardiopulmonary ResuscitationElevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation | Device | Head-up Cardiopulmonary Resuscitation |
Primary outcome
Number and portion of participants with serious or non-serious adverse event
Time frame: Up to 1 day
e.g. event of fall, failure of intubation
3 secondary outcomes
Number and portion of participants with repeated CPR
Time frame: up to 1 day
Number and portion of participants with survival to emergency department discharge
Time frame: up to 1 day
Number and portion of participants with sustained return of spontaneous circulation
Time frame: Up to 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Ting Chen principal investigator
National Taiwan University Hospital
Chien-Hua Huang principal investigator
National Taiwan University Hospital
Min-Shan Tsai principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-up Cardiopulmonary Resuscitation in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hsien Lin (+886972653698, 47ienn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and portion of participants with serious or non-serious adverse event (time frame: Up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.