NCT02387775

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

Temperature Control With an Esophageal Cooling Device: A Feasibility Study in Post Cardiac Arrest Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Temperature control in comatose survivors of cardiac arrest, is a critical aspect of these patients' care. In this context, mild temperature reduction for 24 hours post cardiac arrest has been shown to improve neurological outcomes. Hypothermia is commonly induced using a combination of internal and external cooling modalities. Internal cooling modalities include intravenous administration of cold crystalloids and intravascular cooling catheters. External or body surface cooling can be achieved using cooling blankets, adhesive pads, and ice packs. Each of these methods however, has its limitations. Administration of intravenous refrigerated crystalloid (4°C) boluses is a simple, effective and widely available method of hypothermia induction. Lack of precise temperature control and the potential for pulmonary edema however, make this modality unsuitable for the maintenance phase of hypothermia. Surface cooling methods, such as cooling blankets and ice packs, often cause shivering, skin breakdown, and in obese patients may be ineffective. Intravascular cooling catheters require the time of a physician for insertion and bear the potential risks of line infection and deep venous thrombosis. Searching for a temperature control device that overcomes the limitations, inefficiencies and inconveniences of existing modalities is therefore strongly desired. The ideal temperature control modality should be effective, predictable and easy to use. An esophageal cooling device has recently become available which in theory may, may possess some of these attributes. To date, there have been no published studies examining this device's efficacy. In addition, no study has documented any adverse events during it's use, or evaluated it's ease-of-use at the bedside. This is a prospective, interventional study aiming to assess the effectiveness of the Esophageal Cooling Device (ECD) as a temperature control modality in comatose survivors of cardiac arrest (the E-Chill trial). 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

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-06-01
• Completion: 2018-06-15
• First posted: 2015-03-13
• Last updated: 2018-07-30

Locations

2 sites across 1 country: Canada