Esophageal Temperature Management After Cardiac Arrest

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).

Conditions

• Cardiac Arrest

Interventions

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.

Sponsors & Collaborators

• Advanced Cooling Therapy LLC, d/b/a Attune Medical

  collaborator INDUSTRY

• Erik Kulstad, MD

  collaborator UNKNOWN

• IST cardiology

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• France

Study Locations