NCT02030236

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

January 7, 2014

Last Update Submit

March 3, 2014

Conditions

Hypothermia.

Keywords

hypothermia, inducedrewarmingtherapeuticheart arrestasystolefrostbite

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour.

Secondary Outcomes (4)

  • Skin condition.

    3 days.

  • ECG abnormalities.

    3 hours.

  • Sepsis.

    3 days.

  • Skin condition.

    3 days.

Study Arms (1)

Cooling

EXPERIMENTAL
Device: Cooling

Interventions

CoolingDEVICE

Temperature reached Duration of exposure to cold.

Also known as: CAERvest prototype
Cooling

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIRU, Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 11856793BACKGROUND

  • Seupaul 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.

    PMID: 21435740BACKGROUND

Related Links

MeSH Terms

Conditions

HypothermiaHeart ArrestFrostbite

Interventions

Cool-Down Exercise

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesCold InjuryWounds and Injuries

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rowland L Cottingham, FRCS FCEM

    Brighton and Sussex Universities Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rowland L Cottingham, FRCS FCEM

CONTACT

+44 1273 696955rowley.cottingham@bodychillz.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

GB(1)