Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest

Cardiac Arrest Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071797
• Other study ID #: B626
• Secondary ID: 12/EE/0472
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2020
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reduce tympanic temperature to < 34C		Day 1
Secondary	In hospital and 30 day mortality		Day 30
Secondary	Length of Intensive Care Unit stay		Day 30