Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest
NCT ID: NCT02071797
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2013-01-31
2015-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A - Blanketroll lll
Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care
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
Arm B - RhinoChill
Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Post cardiac arrest with Return of Spontaneous Circulation
3. Receiving therapeutic hypothermia as part of post-cardiac arrest care
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Mid and South Essex NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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John R Davies, MBBS MRCP
Role: STUDY_DIRECTOR
BTUH
Locations
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The Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom
Countries
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References
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Islam S, Hampton-Till J, Watson N, Mannakkara NN, Hamarneh A, Webber T, Magee N, Abbey L, Jagathesan R, Kabir A, Sayer J, Robinson N, Aggarwal R, Clesham G, Kelly P, Gamma R, Tang K, Davies JR, Keeble TR. Early targeted brain COOLing in the cardiac CATHeterisation laboratory following cardiac arrest (COOLCATH). Resuscitation. 2015 Dec;97:61-7. doi: 10.1016/j.resuscitation.2015.09.386. Epub 2015 Sep 26.
Other Identifiers
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12/EE/0472
Identifier Type: OTHER
Identifier Source: secondary_id
B626
Identifier Type: -
Identifier Source: org_study_id