CAERvest® - A Novel Endothermic Hypothermic Device for Core Body Cooling. Safety and Efficacy Testing.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Bodychillz Ltd
Sponsor:
Information provided by (Responsible Party):
Bodychillz Ltd
ClinicalTrials.gov Identifier:
NCT02030236
First received: January 7, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hypothermia.
Device: Cooling

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Bodychillz Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
Experimental: Cooling Device: Cooling
Temperature reached Duration of exposure to cold.
Other Name: CAERvest prototype

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030236

Contacts
Contact: Rowland L Cottingham, FRCS FCEM +44 1273 696955 rowley.cottingham@bodychillz.com

Locations
United Kingdom
CIRU, Royal Sussex County Hospital Not yet recruiting
Brighton, United Kingdom, BN2 5BE
Principal Investigator: Rowland L Cottingham, FRCS FCEM         
Sponsors and Collaborators
Bodychillz Ltd
Investigators
Principal Investigator: Rowland L Cottingham, FRCS FCEM Brighton and Sussex Universities Hospital NHS Trust
  More Information

Additional Information:
Publications:
Responsible Party: Bodychillz Ltd
ClinicalTrials.gov Identifier: NCT02030236     History of Changes
Other Study ID Numbers: CAERvest-001
Study First Received: January 7, 2014
Last Updated: March 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bodychillz Ltd:
hypothermia, induced
rewarming
therapeutic
heart arrest
asystole
frostbite

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014