Most, if not all, patients who are candidates for temperature management will already be sedated or asleep prior to placement of the ECD.
Placement of the ECD does not require additional training beyond that which clinicians receive to place an orogastric tube. The ECD’s wall suction connection is identical to the wall suction connection on a standard orogastric or nasogastric tube, and the ECD’s external heat exchanger connections are designed to connect unambiguously to the external heat exchanger.
Patient temperature is monitored with a standard Foley catheter temperature probe or rectal temperature probe, connected via a standard YSI 400 connector to the external heat exchanger. Because the ECD is located in the esophagus, esophageal temperature probes cannot be used, as they may provide inaccurate readings. The temperature probe is connected to the external heat exchanger to provide feedback control.
The ECD’s maximum cooling rate will vary between patients, but is comparable to devices currently in widespread use.
The ECD fits most average sized adults. The safety and effectiveness of the ECD has not been evaluated in patients with less than 40 kg of body mass.
The ECD is a thermal regulating device intended to connect to an external heat exchanger to control patient temperature in the operating room, recovery room, emergency room, or intensive care unit.
No. The water from the external heat exchanger circulates through the ECD in a closed loop, just like a water blanket.
The ECD is manufactured in the United States.
Yes. The ECD can be used for cooling, warming, and/or maintaining body temperature.
The ECD can be placed by any healthcare provider trained to place orogastric tubes (including nurses, paramedics, and physicians).
The ECD01 and ECD02 are available for sale in Europe, Canada, Australia, and the US.