Study of a New Clinical Device for Reducing Body Core Temperature
Stopped early · Not applicable
Conditions studied: Hypothermia
In brief
This is a descriptive, nonrandomized, noninvasive, single-group, single-center pilot study of a Core Cooling System (CCS) device for reducing core body temperature in ICU patients at University Medical Center Brackenridge (UMCB) and Seton Medical Center Austin (SMCA). The proposed research on human subjects will provide data that will be used to improve a specialized human heat transfer technique/device. By stimulating specialized blood vessels (arteriovenous anastomoses) AVAs in the palm of the hand, it is possible to greatly increase local blood flow and thus greatly increase the potential for effective heat transfer between the environment and body. The hypothesis of this trial is that the Core Cooling System (CCS) will prove to be a practical, safe, and effective method to raise or lower body temperature in critically ill patients.
Key facts
- Study ID
- NCT01996982
- Run by
- Seton Healthcare Family
- People needed
- 7
- Starts
- 2014-03-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2019-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Admitted to UMCB ICU
- Sedated, intubated and or mechanically ventilated
- At least one core temperature measurement device in place (rectal, bladder, pulmonary artery) as standard of care
- Medical/surgical condition is stable enough to permit uninterrupted testing and observation for at least 24 hours
- No medical/surgical procedures are anticipated as necessary or scheduled during testing and observation period that would be affected by this protocol
- Vital signs and other parameters have been stable for at least 12 hours and there are no imminent indications of instability
- LAR available and willing to provide informed consent
You may not qualify if…
- Condition is too unstable to permit uninterrupted testing and observation
- Pregnant and breast feeding patients
- Patients that might worsen with TH, including coagulopathy (INR>1.5), thrombocytopenia (platelet count <100,000)
- Patients on antiplatelet therapy other than aspirin
- Patients on anticoagulants other than prophylactic low molecular weight heparin
- Patients on pressors to maintain blood pressure
- Patients with injuries to extremities that could preclude application of cooling mittens or socks to at least three extremities
- Patients on TH treatment for any other condition
Where it is running
- University Medical Center Brackenridge — Austin, Texas, United States
- Seton Medical Center — Austin, Texas, United States
Full record on ClinicalTrials.gov
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