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

NCT ID: NCT02387775

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-06-15

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esophageal temperature control

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.

Group Type: EXPERIMENTAL

Esophageal temperature control

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Esophageal Cooling Device®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed F. Hegazy, MBBCh, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Western Univeristy, Canada

Locations

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

London, Ontario, Canada

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

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 26481105 (View on PubMed)

Related Links

https://www.youtube.com/watch?v=I3_tySqrwQk

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.

Other Identifiers

106185

Identifier Type: -

Identifier Source: org_study_id