Thermal Compression Device for Maintenance of Perioperative Normothermia
Phase 0 Study of a Thermal Compression Device for Maintenance of Perioperative Normothermia
1 other identifier
interventional
37
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 2, 2017
April 1, 2017
1.8 years
May 27, 2014
April 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Core temperature
average calculated looking for presence of hypothermia (below 36 deg core temp) During surgery, the patient will have their core temperature continuously monitored either via esophageal , tympanic and if available bladder (routine intraoperative monitoring)
Perioperative period
Secondary Outcomes (3)
Thermal comfort
Measured at 15min intervals in the pre ((within 60 minutes prior to induction of anesthesia) and post op period ((within 60 minutes after awakening from anesthesia)
General comfort
15 min intervals in pre ((within 60 minutes prior to induction of anesthesia) and post op period ((within 60 minutes after awakening from anesthesia)
Skin injury scale
15 min intervals during the perioperative period (within 60 minutes prior to induction of anesthesia, during the surgery (expected 3-6 hours) and (within 60 minutes after awakening from anesthesia))
Study Arms (5)
Prototype development
EXPERIMENTAL10 patients (this phase will be terminated once prototype is confirmed ready) Intervention: prototype device
Treatment arm - Prototype
ACTIVE COMPARATOR\- 18 patients Intervention: Prototype device (heating both sole of foot and popliteal fossa with compression)
Control arm - Forced Air Warming Blanket
ACTIVE COMPARATOR18 patients Intervention: Forced air warming blanket (Bair hugger)
Comparison - Sole of foot only
ACTIVE COMPARATOR9 patients heating sole of foot only Intervention: prototype device
Comparison - Popliteal fossa only
ACTIVE COMPARATOR9 patients heating popliteal fossa only Intervention: prototype device
Interventions
Forced Air Warming Blanket placed over the body of the patient during surgery
Contact heating device provides heat to the sole of the foot and popliteal fossa while providing intermittent compression to the lower leg.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University Hopspital
Stanford, California, 94305, United States
Related Publications (1)
Santa Maria PL, Santa Maria C, Eisenried A, Velasquez N, Kannard BT, Ramani A, Kahn DM, Wheeler AJ, Brock-Utne JG. A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy. BMC Anesthesiol. 2017 Aug 11;17(1):102. doi: 10.1186/s12871-017-0395-2.
PMID: 28800725DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter L Santa Maria, MD PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 27, 2014
First Posted
June 4, 2014
Study Start
August 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 2, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
De-identified datasets