Thermal Compression Device for Maintenance of Perioperative Normothermia
Completed · Not applicable
Conditions studied: Hypothermia
In brief
Getting cold (not maintaining normothermia) around surgery (perioperative period) leads to many negative outcomes for patients including increased wound complications, abnormal heart rhythms and increased blood loss. These all lead to increased length of hospital stay and higher requirements for post operative monitoring. These add to around $3500 of extra costs per patient. The investigators aim to study the effects of a warming device, placed around the patient's legs and/or feet, to determine it's safety, efficacy and eventually compare to the current gold standard of a forced air warming blanket. Forced air warming has been associated with the spread of germs over the surgical field. Hence the need for warming equipment that won't do that.
Key facts
- Study ID
- NCT02155400
- Run by
- Stanford University
- People needed
- 37
- Starts
- 2014-08-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2017-05-02
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients undergoing procedures with general anesthesia, lasting longer than 30 minutes, that have a leg size that fits a medium sized sequential compression device (DVT leg device) are eligible.
You may not qualify if…
- - patients in which procedure hypothermia is desired (eg. some cardiac patients)
- do not have 2 legs for the device to be applied.
- have disease of the legs with altered sensation or may have increased tissue sensitivity to leg warming (peripheral neuropathy, peripheral vascular disease, active legs infections etc)
- patients considered not appropriate by either the attending anesthesiologist or surgeon.
Where it is running
- Stanford University Hopspital — Stanford, California, United States
Full record on ClinicalTrials.gov
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