Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest (COOLCATH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Basildon and Thurrock University Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02071797
First received: January 27, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal cooling system to current standard Blanketrol III cooling blanket in its ability to achieve therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.

The COOLCATH study will be a prospective, open-label randomized controlled trial comparing induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH will be considered for this study.


Condition Intervention
Cardiac Arrest
Device: Induced Therapeutic Hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest. Randomised Controlled Trial of RhinoChill Versus Blanketrol Intra-Hospital Induction of Therapeutic Hypothermia After Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Time to reduce tympanic temperature to < 34C [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In hospital and 30 day mortality [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • Length of Intensive Care Unit stay [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A - Blanketroll lll
Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care
Device: Induced Therapeutic Hypothermia
Head to head, direct comparator of two standard care devices/treatments (RhinoChill versus Blanketroll lll) to assess time to induced therapeutic hypothermia
Other Name: RhinoChill will be compared with Blanketroll lll
Active Comparator: Arm B - RhinoChill
Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care
Device: Induced Therapeutic Hypothermia
Head to head, direct comparator of two standard care devices/treatments (RhinoChill versus Blanketroll lll) to assess time to induced therapeutic hypothermia
Other Name: RhinoChill will be compared with Blanketroll lll

Detailed Description:

According to standard practice patients will be fully anaesthetised, intubated and ventilated. Patients will have a baseline tympanic temperature measurement taken and then will be randomized to receive induction of TH by either RhinoChill Transnasal cooling system, or standard care using the Blanketrol III cooling blanket.

All patients will have tympanic and oesophageal temperature measurement every 10 minutes until they reach TH (<34 degrees centigrade). Once TH is achieved, the RhinoChill will be discontinued, and all patients will then receive the Blanketrol III cooling blanket for maintenance of TH for the standard 24 hour period. If a patient achieves a core body temp of 34 degrees centigrade while undergoing RhinoChill cooling and is still on the cath lab table, the device will be turned to low flow to ensure that the temperature is maintained until a transfer to the Blanketrol system is possible. For patients that arrive in the ICU on RhinoChill with a temperature >34 (i.e. have not reached TH), these patients will have RhinoChill and blanket therapy until they reach <34 degrees centigrade when the RhinoChill will be discontinued.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old
  2. Post cardiac arrest with Return of Spontaneous Circulation
  3. Receiving therapeutic hypothermia as part of post-cardiac arrest care

Exclusion Criteria:

  1. Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging
  2. Already hypothermic
  3. Nasal obstruction preventing the insertion of a nasal catheter
  4. Do Not Attempt to Resuscitate (DNAR) orders
  5. Known terminal illness (eg. malignancy in the end stages)
  6. Known or obvious pregnancy
  7. Known coagulation disorder (except those induced by medication eg. Thrombolytics)
  8. Known O2- dependency
  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: NCT02071797

Contacts
Contact: John R Davies, MBBS MRCP 08451551111 john.davies@btuh.nhs.uk
Contact: Thomas R Keeble, MB BS MRCP 08451551111 thomas.keeble@btuh.nhs.uk

Locations
United Kingdom
Essex Cardiothoracic Centre Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Contact: Christine VM Mitchell-Inwang, BSc MSc    012680394802    christine.mitchell-inwang@btuh.nhs.uk   
Contact: Carol L Alves, BSc MRes    08451551111 ext 3599    carol.alves@btuh.nhs.uk   
Principal Investigator: John R Davies, MBBS MRCP         
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Investigators
Study Director: John R Davies, MBBS MRCP BTUH
  More Information

No publications provided

Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02071797     History of Changes
Other Study ID Numbers: B626, 12/EE/0472
Study First Received: January 27, 2014
Last Updated: February 28, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
Therapeutic Hypothermia
Cardiac Arrest
Randomised Controlled trial
Pilot study

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014