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Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients

NCT00827957 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-02-10

No results posted yet for this study

Summary

Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.

Conditions

  • Cardiac Arrest

Interventions

DEVICE

Internal Cooling

The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.

DEVICE

External Cooling

The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.

Sponsors & Collaborators

  • National Heart Centre Singapore

    collaborator OTHER

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Marcus EH Ong, MBBS, MPH · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Singapore

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 NCT00827957 on ClinicalTrials.gov