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Thermal Compression Device for Maintenance of Perioperative Normothermia

NCT02155400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-05-02

No results posted yet for this study

Summary

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.

Conditions

  • Hypothermia

Interventions

DEVICE

Bair Hugger

Forced Air Warming Blanket placed over the body of the patient during surgery

DEVICE

Prototype / Experimental device

Contact heating device provides heat to the sole of the foot and popliteal fossa while providing intermittent compression to the lower leg.

Sponsors & Collaborators

Principal Investigators

  • Peter L Santa Maria, MD PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155400 on ClinicalTrials.gov