Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients (NCT02387775) | Clinical Trial Compass
CompletedNot Applicable
Temperature Control With an Esophageal Cooling Device in Post Cardiac Arrest Patients
Canada15 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of time maintained within 0.5°C range of the 35°C input target, in the hypothermia maintenance phase.
Timeframe: Within 36 hours of ECD insertion.
Trial details
NCT IDNCT02387775
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's