NCT02071797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

January 27, 2014

Last Update Submit

December 21, 2020

Conditions

Cardiac Arrest

Keywords

Therapeutic HypothermiaCardiac ArrestRandomised Controlled trialPilot study

Outcome Measures

Primary Outcomes (1)

  • Time to reduce tympanic temperature to < 34C

    Day 1

Secondary Outcomes (2)

  • In hospital and 30 day mortality

    Day 30

  • Length of Intensive Care Unit stay

    Day 30

Study Arms (2)

Arm A - Blanketroll lll

ACTIVE COMPARATOR

Cutaneous Cooling Blanket, Blanketroll lll, applied to cool patient to 32C. Standard care

Device: Induced Therapeutic Hypothermia

Arm B - RhinoChill

ACTIVE COMPARATOR

Intra nasal cooling system, RhinoChill, to cool patient to 32C - Standard care

Device: Induced Therapeutic Hypothermia

Interventions

Induced Therapeutic HypothermiaDEVICE

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

Also known as: RhinoChill will be compared with Blanketroll lll
Arm A - Blanketroll lllArm B - RhinoChill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • Post cardiac arrest with Return of Spontaneous Circulation
  • Receiving therapeutic hypothermia as part of post-cardiac arrest care

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

Related 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.

    PMID: 26410565BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • John R Davies, MBBS MRCP

    BTUH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 26, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

GB(1)