A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy
Abstract Background Inadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa a...
Main Authors: | , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2017-08-01
|
Series: | BMC Anesthesiology |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12871-017-0395-2 |
id |
doaj-e9a9a9a3cf3d40f1ba92230ba9fb1be8 |
---|---|
record_format |
Article |
spelling |
doaj-e9a9a9a3cf3d40f1ba92230ba9fb1be82020-11-25T03:12:00ZengBMCBMC Anesthesiology1471-22532017-08-0117111310.1186/s12871-017-0395-2A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacyPeter Luke Santa Maria0Chloe Santa Maria1Andreas Eisenried2Nathalia Velasquez3Brian Thomas Kannard4Abhinav Ramani5David Mark Kahn6Amanda Jane Wheeler7John Gerhard Brock-Utne8Department of Otolaryngology, Head and Neck Surgery, Stanford UniversityDepartment of Otolaryngology, Head and Neck Surgery, Stanford UniversityDepartment of Anesthesiology, Stanford UniversityDepartment of Otolaryngology, Head and Neck Surgery, Stanford UniversityBiodesign, Stanford UniversityBiodesign, Stanford UniversityDepartment of Plastic Surgery, Stanford UniversityDepartment of General Surgery, Stanford UniversityDepartment of Anesthesiology, Stanford UniversityAbstract Background Inadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa and soles of the feet, with lower leg compression, increases perioperative temperatures and reduces IPH compared to the current standard of care. Methods Thirty six female breast surgery patients, at a tertiary academic hospital, were randomized to the device or intraoperative FAW (stage I) with a further 18 patients randomized to the device with a single heating area only (stage II, popliteal fossa or sole of the feet). Stage I: 37 patients recruited (final 36). Stage II: 18 patients recruited (final 18). Inclusion criteria: general anesthesia with esophageal monitoring for over 30 min, legs available and able to fit the device and no contraindications to leg heating or compression. The intervention was: Stage I: Investigational prototype thermal compression device (full device group) or intraoperative FAW. Stage II: Device with only a single heating location. Primary outcomes were perioperative temperatures and incidence of IPH. Secondary outcomes were local skin temperature, general and thermal comfort scores and presence of perioperative complications, including blood loss. Results Mean temperatures in the full device group were significantly higher than the FAW group in the pre-operative (36.7 vs 36.4 °C, p < 0.001), early intraoperative (36.3 vs 35.9 °C, p < 0.001), intraoperative (36.6 vs 36.2 °C, p < 0.001) and postoperative periods (36.8 vs 36.5 °C, p < 0.001). The incidence of IPH in the device group was also significantly lower (16.7% vs 72.0%, p = 0.001). Thermal comfort scores were significantly higher in the full device group and hypothermia associated wound complications were higher in the FAW group. Conclusions The thermal compression device is feasible and has efficacy over the FAW. Further studies are recommended to investigate clinically significant outcomes. Trial registration clinicaltrials.gov ( NCT02155400 )http://link.springer.com/article/10.1186/s12871-017-0395-2Perioperative normothermiaThermal compressionPerioperative warmingForced air warming |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Peter Luke Santa Maria Chloe Santa Maria Andreas Eisenried Nathalia Velasquez Brian Thomas Kannard Abhinav Ramani David Mark Kahn Amanda Jane Wheeler John Gerhard Brock-Utne |
spellingShingle |
Peter Luke Santa Maria Chloe Santa Maria Andreas Eisenried Nathalia Velasquez Brian Thomas Kannard Abhinav Ramani David Mark Kahn Amanda Jane Wheeler John Gerhard Brock-Utne A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy BMC Anesthesiology Perioperative normothermia Thermal compression Perioperative warming Forced air warming |
author_facet |
Peter Luke Santa Maria Chloe Santa Maria Andreas Eisenried Nathalia Velasquez Brian Thomas Kannard Abhinav Ramani David Mark Kahn Amanda Jane Wheeler John Gerhard Brock-Utne |
author_sort |
Peter Luke Santa Maria |
title |
A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
title_short |
A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
title_full |
A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
title_fullStr |
A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
title_full_unstemmed |
A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
title_sort |
novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy |
publisher |
BMC |
series |
BMC Anesthesiology |
issn |
1471-2253 |
publishDate |
2017-08-01 |
description |
Abstract Background Inadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa and soles of the feet, with lower leg compression, increases perioperative temperatures and reduces IPH compared to the current standard of care. Methods Thirty six female breast surgery patients, at a tertiary academic hospital, were randomized to the device or intraoperative FAW (stage I) with a further 18 patients randomized to the device with a single heating area only (stage II, popliteal fossa or sole of the feet). Stage I: 37 patients recruited (final 36). Stage II: 18 patients recruited (final 18). Inclusion criteria: general anesthesia with esophageal monitoring for over 30 min, legs available and able to fit the device and no contraindications to leg heating or compression. The intervention was: Stage I: Investigational prototype thermal compression device (full device group) or intraoperative FAW. Stage II: Device with only a single heating location. Primary outcomes were perioperative temperatures and incidence of IPH. Secondary outcomes were local skin temperature, general and thermal comfort scores and presence of perioperative complications, including blood loss. Results Mean temperatures in the full device group were significantly higher than the FAW group in the pre-operative (36.7 vs 36.4 °C, p < 0.001), early intraoperative (36.3 vs 35.9 °C, p < 0.001), intraoperative (36.6 vs 36.2 °C, p < 0.001) and postoperative periods (36.8 vs 36.5 °C, p < 0.001). The incidence of IPH in the device group was also significantly lower (16.7% vs 72.0%, p = 0.001). Thermal comfort scores were significantly higher in the full device group and hypothermia associated wound complications were higher in the FAW group. Conclusions The thermal compression device is feasible and has efficacy over the FAW. Further studies are recommended to investigate clinically significant outcomes. Trial registration clinicaltrials.gov ( NCT02155400 ) |
topic |
Perioperative normothermia Thermal compression Perioperative warming Forced air warming |
url |
http://link.springer.com/article/10.1186/s12871-017-0395-2 |
work_keys_str_mv |
AT peterlukesantamaria anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT chloesantamaria anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT andreaseisenried anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT nathaliavelasquez anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT brianthomaskannard anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT abhinavramani anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT davidmarkkahn anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT amandajanewheeler anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT johngerhardbrockutne anovelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT peterlukesantamaria novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT chloesantamaria novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT andreaseisenried novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT nathaliavelasquez novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT brianthomaskannard novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT abhinavramani novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT davidmarkkahn novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT amandajanewheeler novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy AT johngerhardbrockutne novelthermalcompressiondeviceforperioperativewarmingarandomizedtrialforfeasibilityandefficacy |
_version_ |
1724651978166894592 |