Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02071797

Acronym

COOLCATH

Enrollment

Registered

2014-02-26

Start date

2013-01-31

Completion date

2015-07-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Therapeutic Hypothermia, Cardiac Arrest, Randomised Controlled trial, Pilot study

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.

Interventions

DEVICEInduced Therapeutic Hypothermia

Head to head, direct comparator of two standard care devices/treatments (RhinoChill versus Blanketroll lll) to assess time to induced therapeutic hypothermia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to reduce tympanic temperature to < 34C	Day 1

Secondary

Measure	Time frame
Length of Intensive Care Unit stay	Day 30
In hospital and 30 day mortality	Day 30

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026