Trial Outcomes & Findings for Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device (NCT NCT02420639)

Results Overview

Time to initiation of targeted temperature management, as measured from the time a decision is made to begin targeted temperature management, to the time the esophageal cooling device is in place.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

30 days

Results posted on

2021-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III). Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=12 Participants The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III). Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature.
Age, Continuous	42 years STANDARD_DEVIATION 16 • n=12 Participants
Sex: Female, Male Female	1 Participants n=12 Participants
Sex: Female, Male Male	11 Participants n=12 Participants
Region of Enrollment Ukraine	12 participants n=12 Participants
BMI	25.3 kg/m^2 STANDARD_DEVIATION 2.3 • n=12 Participants

PRIMARY outcome

Timeframe: 30 days

Time to initiation of targeted temperature management, as measured from the time a decision is made to begin targeted temperature management, to the time the esophageal cooling device is in place.

Outcome measures

Outcome measures
Measure	Intervention n=12 Participants The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III). Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature.
Time to Initiation of Temperature Management	5.83 hours Standard Deviation 5

SECONDARY outcome

Timeframe: 36 hours

Secondary performance outcomes include the feasibility of inducing, maintaining, and rewarming patients from targeted temperature management using the Esophageal Cooling Device. Specifically, cooling rate, rewarming rate, and the percent of time during the goal- temperature maintenance period within 1°C of goal temperature (typically 33°C, but with some centers using anywhere from 32°C to 36°C) will be measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed over 36 hours of treatment and up to 30 days of follow-up.

Secondary safety outcomes include evaluation of 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.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=12 participants at risk The placement of the Esophageal Cooling Device will follow standard recommendations as per Instructions for Use. The Esophageal Cooling Device will be connected to the appropriate console (Meditherm III, Blanketrol II, or Blanketrol III). Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.: Use of the Esophageal Cooling Device for control of patient temperature. Adverse events specifically monitored included the following: cardiac arrhythmias, severe bradycardia, myocardial infarction/reinfarction, dysphagia, odynophagia, aspiration pneumonia, nonaspiration pneumonia, reflux, esophageal injury, and esophagitis.
Respiratory, thoracic and mediastinal disorders a small volume left hydrothorax	8.3% 1/12 • Number of events 1 • 30 days

Additional Information

Alexander Tsarev

Department of Anesthesiology & Intensive Care Medicine, Dnipropetrovsk Medical Academy

Phone: +38 057 701 52 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place