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Esophageal Temperature Management After Cardiac Arrest (THE-COOL)

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ClinicalTrials.gov Identifier: NCT02327871
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Advanced Cooling Therapy, LLC
Erik Kulstad, MD
Information provided by (Responsible Party):
IST cardiology

Brief Summary:

To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients. However, available modalities for inducing TH have a number of technical (side effects), logistical (difficulties of placement), and financial (cost) barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a device that potentially improves the effectiveness of TH in minimizing the risks of existing methods (such as invasive cooling). Initial mathematical and animal studies have shown strong support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is a systematic standard of care for all unconscious patients suffering from CA. The present study will replace the usual naso-gastric probe by the ECD that can be used for gastric suctioning as usually done in such patients.

The aim of this prospective, interventional study is to assess the feasibility and safety of the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from TH using the ECD (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury, and esophagitis) will be closely monitored during the whole period of the targeted temperature management (secondary endpoint).


Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: Esophageal cooling device (and usual standard procedure) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Temperature Management With Therapeutic Hypothermia Using Esophageal COOLing After Cardiac Arrest: THE COOL STUDY
Actual Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Esophageal cooling
Specific treatment: The placement of the ECD will follow standard recommendations as per Instructions for Use. The ECD will be connected to the Gaymar console (Meditherm III, Gamida, France). In our institution, TH is performed in all patients resuscitated from an OHCA except those presenting exclusion criteria. TH can be initiated as soon as possible by administration of cold saline at 4°C if necessary followed by application of the available cooling device (blankets, endovascular methods, etc) aiming a target temperature of 32-34°C for 24 hours as recommended. 8-11,13 For all enrolled patient, the ECD will hereby replace the other cooling device usually used in our ICU.
Device: Esophageal cooling device (and usual standard procedure)
Standard treatments for resuscitation after CA will follow local, national, and international guidelines. Core temperature is measured using urinary Foley catheters and/or arterial temperature monitoring if available. During TH, sedation and analgesia is performed in routine. Neuromuscular blockade is induced to favor cooling and prevent shivering if necessary. Circulatory function is monitored by arterial catheter if necessary and blood pressure is maintained as usually. Hypotension is treated with dobutamine catecholamines titrated according cardiac output monitored using echocardiogram, or PiCCO® systems. Fluid management is left at the discretion of the attending physician. Prognostication after CA uses serial clinical examinations, biomarkers, transcranial Doppler, Electro-Encephalo-Gram, cerebral CT-scan or MRI, and/or Somato-Sensory-Evoked-Potential.
Other Name: ECD




Primary Outcome Measures :
  1. The percent of time over the study period within 1°C of goal temperature (33°C) . [ Time Frame: Targeted temperature management phase (TH) within the first 48 hours after inclusion ]

Secondary Outcome Measures :
  1. Percentage of patients for whom the ECD maintained goal temperature +/-1°C for 85% of the time during the maintenance 33°C phase . [ Time Frame: Targeted temperature management phase (TH) within the first 48 hours after inclusion ]
  2. Composite adverse events including the following: cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and esophagitis. [ Time Frame: Until three months (follow-up) after inclusion ]
  3. Global and neurologic outcome will be assessed using the Overall (OPC) and the Cerebral Performance Category (CPC) score with blinded evaluation of the mid- and long-term neurological outcome [ Time Frame: up to follow-up at 3 months after inclusion ]
    assessment by a independent physician unaware of the esophageal cooling



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age over 18 years)
  • Successfully resuscitated from an out-of-hospital CA
  • With sustained ROSC (ROSC maintained for >20/minutes)
  • Admitted in the ICU
  • Comatose (not obeying to verbal command)
  • And treated with TH targeted to 32-34°C

Exclusion Criteria:

  • Patient < 18 y.o.
  • Patients with known esophageal deformity, or evidence of esophageal trauma, or previous esophageal disease (for example, known esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders or dysphagia, achalasia, known ingestion of acidic or caustic poisons within the prior 24 hours etc.).
  • Patients with less than 40 kg of body mass.
  • Female patients known to be pregnant.
  • Terminal disease or "do not resuscitate order" that could lead to early-onset therapeutic withdrawal (<48 hours after collapse).
  • Unstable ROSC (defined as impossibility to maintain ROSC with palpable pulse for >20/minutes), or unstable hemodynamic conditions (defined as intractable severe cardiogenic shock or ECLS requiring) that could lead to multi-organ failure and early-onset death (<48 hours after collapse).
  • Accidental hypothermia or hypothermia <30°C at admission
  • Prolonged delay between CA and ROSC (i.e. time to ROSC > 60min)
  • Prolonged delay between ROSC and inclusion > 360min
  • Conscious patient (obeying to verbal command before starting TH)
  • Severe bleeding or diathesis or uncontrolled hemorrhage before inclusion
  • Esophageal bleeding before ECD insertion
  • Pre-existing severe conductive disorder requiring pacing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327871


Locations
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France
Lariboisère
Paris, France, 75000
Sponsors and Collaborators
IST cardiology
Advanced Cooling Therapy, LLC
Erik Kulstad, MD

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Responsible Party: IST cardiology
ClinicalTrials.gov Identifier: NCT02327871     History of Changes
Other Study ID Numbers: IDRCB 2014: AO-1145-42
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by IST cardiology:
Therapeutic hypothermia
patients
Safety, Efficacy

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases