Hypothermia.NCT02030236
CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.
A study testing Cooling in people with Hypothermia., run by Bodychillz Ltd at 1 site in United Kingdom.
Trial summary
Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia.
- What is being tested?
- Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to May 2014
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Human volunteers aged over 18. The upper age limit, as is standard for risk mitigation in such studies, is 35. The volunteer must have capacity to understand the trial and give informed consent to participate. If the volunteer's first language is not English we will make use of Sussex Interpreting Services, a professional interpreting service.
Who cannot join
- Pregnancy. Any disclosed medical condition. Any medical condition detected on examination. Core temperature outside stated parameters.
- We will ask the volunteer to confirm that they are otherwise healthy, taking no regular medication (except the oral contraceptive pill), are not using recreational drugs and have no significant past medical history, in particular cardiovascular disease of any sort, thyroid disease, diabetes mellitus or other metabolic disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CIRU, Royal Sussex County Hospital
Brighton, BN2 5BE
Rowland L Cottingham, FRCS FCEM
About this study
Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.
The device is a prototype cooling vest. The investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree Centigrade an hour to initiate cooling. What the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. That means some of the initial prototypes will not resemble what we expect the eventual device to look like. The investigators will be undertaking the initial trials on 30 normal volunteers.
- Conditions
- Hypothermia.
- Being tested
- Cooling
- Keywords
- hypothermia, induced, rewarming, therapeutic, heart arrest, asystole, frostbite
- Medical subject headings
- Hypothermia, Heart Arrest, Frostbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolingDevice
Also called CAERvest prototype
Temperature reached Duration of exposure to cold.
| Study group | Role | What they receive |
|---|---|---|
| Cooling | Experimental | Not described Receives: Device: Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in core body temperature by 1 degree Centigrade.
The cooling properties of the vest are under investigation, and this reduction is the primary outcome measure.
Measured: 1 hour.
Secondary outcomes (4)
Skin condition.
As the cooling is performed by a cold vest applied directly to the skin we need to ensure that no skin damage is caused.
Measured: 3 days.
ECG abnormalities.
ECG abnormalities: ECG abnormalities are common after cardiac arrest, and have been noted in cooled patients after cardiac arrest. We will monitor the ECG for any abnormalities. The following will be noted but will not terminate the study:
Bradycardia of less than 15 beats per minute below baseline. Unifocal ventricular ectopics. Unifocal atrial ectopics. Any other cardiac abnormality will cause immediate termination of the study and intervention to treat as necessary. A defibrillator will be available in the study room.
Measured: 3 hours.
Sepsis.
Sepsis: Increased rates of sepsis have been seen in intensive care units in patients who have received therapeutic hypothermia. We will enquire about sepsis symptoms in our follow-up contact.
Measured: 3 days.
Skin condition.
Our aim is not to cause any skin damage to patients or volunteers. We will therefore inspect the skin after removing the vest or at any time before that if the volunteer expresses concern. We expect pallor of the skin during cooling and reddening during rewarming with some numbness and some discomfort, both during cooling and rewarming. We will regard any evidence of frostbite as a serious untoward injury (SUI) and this will result in suspension of the study and an investigation into the specific vest used and the general vest design and formulation. We regard this as a serious risk but highly unlikely in practice.
Measured: 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypothermia.Studies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bodychillz Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rowland L Cottingham, FRCS FCEM, Principal investigator, Brighton and Sussex Universities Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030236
- Sponsor's protocol ID
- CAERvest-001
- Status last verified
- Mar 2014
- First submitted
- 7 Jan 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
PubMed 11856793Seupaul RA, Wilbur LG. Evidence-based emergency medicine. Does therapeutic hypothermia benefit survivors of cardiac arrest? Ann Emerg Med. 2011 Sep;58(3):282-3. doi: 10.1016/j.annemergmed.2011.02.002. Epub 2011 Mar 24. No abstract available.
PubMed 21435740
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.
- ClinicalTrials.gov ID
- NCT02030236
- Acronym / sponsor ID
- CAERvest-001
- Conditions
- Hypothermia.
- Keywords
- hypothermia, induced, rewarming, therapeutic, heart arrest, asystole, frostbite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bodychillz LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 8 Jan 2014 (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.
Cooling the whole body to 32-34 degrees Centigrade from the normal of around 37 degrees Centigrade for 24 hours has been shown to be an effective way of reducing damage to brain function after return of spontaneous circulation when someone has been resuscitated from cardiac arrest. Cardiac arrest is a form of heart attack where the heart stops pumping.
The device is a prototype cooling vest. The investigators anticipate that this will be useful in ambulances, helicopters and emergency departments where there is a need for a portable, safe, easy-to-use, inexpensive, external, effective, readily-controlled and single-patient use device able to reduce body temperature by at least 1 degree Centigrade an hour to initiate cooling. What the investigators are doing in these trials is to demonstrate that the investigators can cool people and to get the best design possible for patient use. That means some of the initial prototypes will not resemble what we expect the eventual device to look like. The investigators will be undertaking the initial trials on 30 normal volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling | Experimental | Device: Cooling |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Human volunteers aged over 18. The upper age limit, as is standard for risk mitigation in such studies, is 35. The volunteer must have capacity to understand the trial and give informed consent to participate. If the volunteer's first language is not English we will make use of Sussex Interpreting Services, a professional interpreting service.
Key exclusion criteria (2 listed)
- Pregnancy. Any disclosed medical condition. Any medical condition detected on examination. Core temperature outside stated parameters.
- We will ask the volunteer to confirm that they are otherwise healthy, taking no regular medication (except the oral contraceptive pill), are not using recreational drugs and have no significant past medical history, in particular cardiovascular disease of any sort, thyroid disease, diabetes mellitus or other metabolic disease.
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 |
|---|---|---|
| CoolingAlso: CAERvest prototypeTemperature reached Duration of exposure to cold. | Device | Cooling |
Primary outcome
Reduction in core body temperature by 1 degree Centigrade.
Time frame: 1 hour.
The cooling properties of the vest are under investigation, and this reduction is the primary outcome measure.
4 secondary outcomes
Skin condition.
Time frame: 3 days.
ECG abnormalities.
Time frame: 3 hours.
Sepsis.
Time frame: 3 days.
Skin condition.
Time frame: 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Background: PubMed 11856793Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
- Background: PubMed 21435740Seupaul RA, Wilbur LG. Evidence-based emergency medicine. Does therapeutic hypothermia benefit survivors of cardiac arrest? Ann Emerg Med. 2011 Sep;58(3):282-3. doi: 10.1016/j.annemergmed.2011.02.002. Epub 2011 Mar 24. No abstract available.
- Our study location.Link provided by the sponsor.
- UK health regulatory authority.Link provided by the sponsor.
- The UK MHRA.Link provided by the sponsor.
Related trials for Hypothermia.
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
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.
Rowland L Cottingham, FRCS FCEM principal investigator
Brighton and Sussex Universities Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling in people with Hypothermia., run by Bodychillz Ltd at 1 site in United Kingdom.
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 2 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 4 Mar 2014. 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 United Kingdom. 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 Rowland L Cottingham, FRCS FCEM (+44 1273 696955, rowley.cottingham@bodychillz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in core body temperature by 1 degree Centigrade. (time frame: 1 hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030236, which also lists 2 linked publications.
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 4 Mar 2014.