Clinical trial NCT02071797: Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Therapeutic Hypothermia
Cardiac Arrest
Randomised Controlled trial
Pilot study
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Time to reduce tympanic temperature to < 34C
timeFrame: Day 1
Secondary outcomes:
measure: In hospital and 30 day mortality
timeFrame: Day 30
measure: Length of Intensive Care Unit stay
timeFrame: Day 30
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: BTUH
name: John R Davies, MBBS MRCP
role: STUDY_DIRECTOR
References:
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.