Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients

NCT02387775 | Completed

• 1 other identifier: 106185
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in post cardiac arrest patients. In addition, observed adverse events during ECD use, ease-of-use, nurse satisfaction and patient outcomes will be examined.

Conditions

Anoxic Brain Injury; Cardiac Arrest

Keywords

esophageal cooling device; post cardiac arrest; targetted temperature management; therapeutic hypothermia; cooling; rewarming

Outcome Measures

Primary Outcomes (1)

• Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.

  Once patient temperature is within 0.5°C from the 35°C target, the maintenance phase will commence. The amount of time patient temperature is maintained within ± 0.5 from 35°C, as a percentage of the total hypothermia maintenance time (24 hours) will be examined. Confidence intervals for the results will be reported.

  Within 36 hours of ECD insertion.

Secondary Outcomes (7)

• Cooling rate in hypothermia induction phase.

  Within 10 hours of ECD insertion.

• Percent of time patient temperature is within 0.5°C range of the input target, 30 minutes after each target elevation in the rewarming phase.

  Within 36 hours of ECD insertion.

• ECD insertion time.

  Within 4 hours of enrollment.

• Adverse events during and after ECD use.

  Within 4 weeks of enrollment or until hospital discharge whichever comes first.

• Ease-of-use.

  Within 40 hours of enrollment.

Other Outcomes (1)

• Shivering during ECD use.

  Within 36 hours of ECD insertion.

Study Arms (1)

Esophageal temperature control

EXPERIMENTAL

The Esophageal Cooling Device (ECD) will be inserted and utilized for temperature control for up to 36 hours in this arm. The ECD will be used for all three phases of therapeutic hypothermia; induction, maintenance, and rewarming. Conventional cooling or warming techniques (e.g. cold saline, ice packs, cooling or warming blankets) will still be made available to the treating ICU team to be used at their discretion.

Device: Esophageal temperature control

Interventions

Esophageal temperature control DEVICE

Insertion of the Esophageal Cooling Device (ECD) will take place as described in the product monograph. The ECD will be connected to the heat exchange unit Blanketrol Hyper-Hypothermia System® (Cincinnati Sub-Zero, Cincinnati, OH) and will be used for temperature control for a total of 36 hours. A patient target of 35°C will be set on the heat exchange unit. Once target is attained, it will be maintained for 24 hours. Slow rewarming will then be achieved by increasing the input target by 0.2°C per hour, until a target of 36.6°C is reached. All temperature data (device, input target, and patient bladder temperature) will be captured automatically using Data Export Software® (Cincinnati Sub-Zero, Cincinnati, OH) on an external laptop connected to the external heat exchange unit.

Also known as: Esophageal Cooling Device®

Esophageal temperature control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the intensive care unit after resuscitation from an out-of-hospital cardiac arrest.
• Sustained return of spontaneous circulation (no chest compressions required for \>20 minutes)
• Not obeying commands to verbal instruction.
• On mechanical ventilation via endotracheal tube or tracheotomy.

You may not qualify if:

• Known esophageal deformity (known esophageal varices, history of esophagectomy, previous swallowing disorders, achalasia, etc.) or evidence of esophageal trauma.
• Known ingestion of acidic or caustic poisons within the prior 24 hours.
• Patients with less than 40 kg of body mass.
• Patients known to be pregnant.
• Uncontrolled coagulopathy.
• Documented intracranial hemorrhage.
• Patients presenting to the intensive care unit with a temperature \< 35°C.
• Time from collapse to return of spontaneous circulation \> 45 minutes or unknown.
• Time from collapse to starting chest compressions \> 10 minutes or unknown.
• Time from collapse to assessment for enrollment \> 12 hours.
• Patients thought to have a very low chance of surviving the next 48 hours as assessed by the research team.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator

Study Sites (2)

University Hospital, London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

Victoria Hospital, London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Hegazy AF, Lapierre DM, Butler R, Althenayan E. Temperature control in critically ill patients with a novel esophageal cooling device: a case series. BMC Anesthesiol. 2015 Oct 19;15:152. doi: 10.1186/s12871-015-0133-6.

  PMID: 26481105 BACKGROUND

Related Links

• The esophageal cooling device insertion steps, the heat exchange unit set-up, our local practice at London Health Sciences Centre, and some general recommendations on the device's use.

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Heart Arrest

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases

Study Officials

• Ahmed F. Hegazy, MBBCh, FRCPC

  Western Univeristy, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 15, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-05

Locations

CA (2)