Cardiac ArrestNCT00154674
Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation
A study testing ICY catheter, Thermoguard device in people with Cardiac Arrest, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- ICY catheter, Thermoguard device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2005to Oct 2005
- 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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points.
Who cannot join
- 1. Age > 78 y/o or < 18 y/o 2. Core temperature< 34℃or > 38 ℃ after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei, 100
Chiung Yuan Hsu, MD, 886-2-23123456 ext. 5926, dtemer01@yahoo.com.tw
About this study
Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients.
Read the detailed description
We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices. Internal cooling catheter, "ICY" , and thermal regulator device, "Coolguard 2000" are applied to the patients from femoral vein. WE definite 4 stages according to the temperature during the clinical trial: "The Cooling Phase", "Hypothermia phase", "Rewarming phase", and "Postrewarming phase". The temperature is lowed or elevated by the rate 0.5C/hr during the Cooling and Rewarming Phase, and it is maintained 33 +/- 1 C during hypothermia phase for 12 hours according to the comment of ACLS. To understand the safety and feasibility, regular blood sampling, bedside EEG and vital monitors, and special sheets are designed to document the every reasons, time points or every clinical events during hypothermia therapy. The patients is observed until rewarming finish for 48 hours or till death if expired during post-resuscitation hypothermia therapy.
- Conditions
- Cardiac Arrest
- Being tested
- ICY catheter, Thermoguard device
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICY catheter, Thermoguard deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
complications and feasibility of endovascular cooling device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Study completionOct 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen Jone Chen, PHD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154674
- Sponsor's protocol ID
- 25MD03
- Status last verified
- Jan 2004
- First submitted
- 8 Sep 2005
- Last updated
- 22 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT00154674
- Acronym / sponsor ID
- 25MD03
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Oct 2005
- First posted
- 12 Sep 2005 (estimated)
- 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.
Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients.
Detailed description
We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices. Internal cooling catheter, "ICY" , and thermal regulator device, "Coolguard 2000" are applied to the patients from femoral vein. WE definite 4 stages according to the temperature during the clinical trial: "The Cooling Phase", "Hypothermia phase", "Rewarming phase", and "Postrewarming phase". The temperature is lowed or elevated by the rate 0.5C/hr during the Cooling and Rewarming Phase, and it is maintained 33 +/- 1 C during hypothermia phase for 12 hours according to the comment of ACLS. To understand the safety and feasibility, regular blood sampling, bedside EEG and vital monitors, and special sheets are designed to document the every reasons, time points or every clinical events during hypothermia therapy. The patients is observed until rewarming finish for 48 hours or till death if expired during post-resuscitation hypothermia therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points.
Key exclusion criteria (1 listed)
- 1. Age > 78 y/o or < 18 y/o 2. Core temperature< 34℃or > 38 ℃ after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP < 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU
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 |
|---|---|---|
| ICY catheter, Thermoguard device | Device | – |
Primary outcome
complications and feasibility of endovascular cooling device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2005.
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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.
Wen Jone Chen, PHD principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICY catheter, Thermoguard device 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 1 inclusion and 1 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 22 Nov 2005. 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 Chiung Yuan Hsu, MD (886-2-23123456 ext. 2831, dtemer01@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications and feasibility of endovascular cooling device. 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 22 Nov 2005.