Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest (COOLCATH)
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Induced Therapeutic Hypothermia
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Arrest focused on measuring Therapeutic Hypothermia, Cardiac Arrest, Randomised Controlled trial, Pilot study
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years old
- Post cardiac arrest with Return of Spontaneous Circulation
- Receiving therapeutic hypothermia as part of post-cardiac arrest care
Exclusion Criteria:
- Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging
- Already hypothermic
- Nasal obstruction preventing the insertion of a nasal catheter
- Do Not Attempt to Resuscitate (DNAR) orders
- Known terminal illness (eg. malignancy in the end stages)
- Known or obvious pregnancy
- Known coagulation disorder (except those induced by medication eg. Thrombolytics)
- Known O2- dependency
Sites / Locations
- The Essex Cardiothoracic Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm A - Blanketroll lll
Arm B - RhinoChill
Arm Description
Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care
Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care
Outcomes
Primary Outcome Measures
Time to reduce tympanic temperature to < 34C
Secondary Outcome Measures
In hospital and 30 day mortality
Length of Intensive Care Unit stay
Full Information
NCT ID
NCT02071797
First Posted
January 27, 2014
Last Updated
December 21, 2020
Sponsor
Mid and South Essex NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02071797
Brief Title
Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest
Acronym
COOLCATH
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid and South Essex NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Therapeutic Hypothermia, Cardiac Arrest, Randomised Controlled trial, Pilot study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A - Blanketroll lll
Arm Type
Active Comparator
Arm Description
Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care
Arm Title
Arm B - RhinoChill
Arm Type
Active Comparator
Arm Description
Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care
Intervention Type
Device
Intervention Name(s)
Induced Therapeutic Hypothermia
Other Intervention Name(s)
RhinoChill will be compared with Blanketroll lll
Intervention Description
Head to head, direct comparator of two standard care devices/treatments (RhinoChill versus Blanketroll lll) to assess time to induced therapeutic hypothermia
Primary Outcome Measure Information:
Title
Time to reduce tympanic temperature to < 34C
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
In hospital and 30 day mortality
Time Frame
Day 30
Title
Length of Intensive Care Unit stay
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years old
Post cardiac arrest with Return of Spontaneous Circulation
Receiving therapeutic hypothermia as part of post-cardiac arrest care
Exclusion Criteria:
Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging
Already hypothermic
Nasal obstruction preventing the insertion of a nasal catheter
Do Not Attempt to Resuscitate (DNAR) orders
Known terminal illness (eg. malignancy in the end stages)
Known or obvious pregnancy
Known coagulation disorder (except those induced by medication eg. Thrombolytics)
Known O2- dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Davies, MBBS MRCP
Organizational Affiliation
BTUH
Official's Role
Study Director
Facility Information:
Facility Name
The Essex Cardiothoracic Centre
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26410565
Citation
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.
Results Reference
background
Learn more about this trial
Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest
We'll reach out to this number within 24 hrs