Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: Induced Therapeutic Hypothermia

• Registration Number: NCT02071797
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-26
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A - Blanketroll lll	Induced Therapeutic Hypothermia	Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care
Arm B - RhinoChill	Induced Therapeutic Hypothermia	Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care

Primary Outcome Measures

Name	Time	Method
Time to reduce tympanic temperature to < 34C	Day 1

Secondary Outcome Measures

Name	Time	Method
In hospital and 30 day mortality	Day 30
Length of Intensive Care Unit stay	Day 30

Trial Locations

Locations (1)

The Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom