CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.
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:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.|
- Reduction in core body temperature by 1 degree Centigrade. [ Time Frame: 1 hour. ] [ Designated as safety issue: No ]The cooling properties of the vest are under investigation, and this reduction is the primary outcome measure.
- Skin condition. [ Time Frame: 3 days. ] [ Designated as safety issue: Yes ]As the cooling is performed by a cold vest applied directly to the skin we need to ensure that no skin damage is caused.
- ECG abnormalities. [ Time Frame: 3 hours. ] [ Designated as safety issue: No ]
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.
- Sepsis. [ Time Frame: 3 days. ] [ Designated as safety issue: Yes ]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.
- Skin condition. [ Time Frame: 3 days. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Temperature reached Duration of exposure to cold.
Other Name: CAERvest prototype
Please refer to this study by its ClinicalTrials.gov identifier: NCT02030236
|Contact: Rowland L Cottingham, FRCS FCEM||+44 1273 firstname.lastname@example.org|
|CIRU, Royal Sussex County Hospital||Not yet recruiting|
|Brighton, United Kingdom, BN2 5BE|
|Principal Investigator: Rowland L Cottingham, FRCS FCEM|
|Principal Investigator:||Rowland L Cottingham, FRCS FCEM||Brighton and Sussex Universities Hospital NHS Trust|