Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients
Keywords
Abstract
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.
Dates
| Last Verified: | 04/30/2018 |
| First Submitted: | 03/08/2015 |
| Estimated Enrollment Submitted: | 03/11/2015 |
| First Posted: | 03/12/2015 |
| Last Update Submitted: | 07/25/2018 |
| Last Update Posted: | 07/29/2018 |
| Actual Study Start Date: | 11/30/2015 |
| Estimated Primary Completion Date: | 05/31/2018 |
| Estimated Study Completion Date: | 06/14/2018 |
Condition or disease
Intervention/treatment
Device: Esophageal temperature control
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: 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. | 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase. [Within 36 hours of ECD insertion.]
Secondary Outcome Measures
1. Cooling rate in hypothermia induction phase. [Within 10 hours of ECD insertion.]
2. 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.]
3. ECD insertion time. [Within 4 hours of enrollment.]
4. Adverse events during and after ECD use. [Within 4 weeks of enrollment or until hospital discharge whichever comes first.]
5. Ease-of-use. [Within 40 hours of enrollment.]
6. Patient neurological outcome as defined by the Cerebral Performance Category. [Within 4 weeks of enrollement or until hospital discharge whichever comes earlier.]
7. Need for other cooling or warming modalities during ECD use. [Within 36 hours of ECD insertion.]
Other Outcome Measures
1. Shivering during ECD use. [Within 36 hours of ECD insertion.]
