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

NCT02387775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-07-30

No results posted yet for this study

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

Interventions

DEVICE

Esophageal temperature control

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.

Sponsors & Collaborators

  • Western University, Canada

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Ahmed F. Hegazy, MBBCh, FRCPC · Western Univeristy, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-06-30
Completion
2018-06-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387775 on ClinicalTrials.gov