Clinical trial NCT00650260: Intraoperative Warming Comparison of Devices
Official title: Intraoperative Warming : Comparison of Performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: intraoperative warming
anesthesia
hypothermia
body temperature
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Dynatherm Medical Inc.
First posted: 2008-04-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.

Various warming methods, such as warm blankets, forced-air warmers and circulating water mattresses, are currently used to prevent and treat mild perioperative hypothermia. All are cutaneous approaches that rely on heating the peripheral tissues in order to increase the thermal core temperature. Application of cutaneous warming system blankets/pads are limited by location/extent of operative site; for example, in certain procedures such as laparatomies, reconstructive plastic surgery or orthopedic surgery, only a limited amount of skin surface is available for warming application. The Dynatherm vitalHEAT technology takes advantage of the body's natural thermoregulatory system to channel thermal energy to the body's core non-invasively at a rapid rate. The vital heat (vH2) system is designed to treat hypothermia during the peri-operative period through a combination of localized heat and vacuum application to one hand \& forearm; this application 1) opens the arteriovenous anastamoses located in the palm of the hand and 2) conductively warms the extremity thus effectively warming the blood flow to the body's core. The vital heat vH2 system is a portable and compact warming device which provides a non-invasive approach to warming patients during surgery.

The primary objective of this study is to determine if the Dynatherm Medical vitalHEAT (vH2) Temperature Management System is as effective as the forced-air warming Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) for maintenance of intraoperative body temperature in patients undergoing abdominal surgery under general anesthesia. The critical endpoints to be evaluated in making this determination are 1) % of subjects with an average intraoperative esophageal temperature of ≥ 36º C and 2) % of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C. Secondary objectives include 1) comparison of the core body temperatures @ 60 minutes post anesthesia induction, 2) comparison of temperature trends during surgery and 3) comparison of the subjects' post anesthesia care unit temperature trends and hypothermic symptoms such as shivering.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective open abdominal surgical procedures with an expected duration of 2 to 4 hours and requiring general anesthesia
* American Society of Anesthesiologists(ASA) physical status I-III
* Patient age: \> 18 years and \<80 years

Exclusion Criteria:

* Patient age: \< 18 years and \>80 years
* Patients with break in skin integrity on the extremity selected as the application site
* Patients with history of upper extremity peripheral vascular disease
* Patients with history of allergic skin conditions of the upper extremities
* Patients with history of bleeding disorders/coagulopathy
* Patient with history of malignant hyperthermia
* Patients who are pregnant
* Patient unwilling or unable to give informed consent

Primary outcomes:
measure: Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius
timeFrame: Intraoperative Period
measure: Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.
timeFrame: Temp taken just prior to surgery
measure: Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius
timeFrame: Upon entry to the post anesthesia care unit
Secondary outcomes:
measure: Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.
timeFrame: 60 minutes post anesthesia induction
measure: Average Intraoperative Esophageal Temperature
timeFrame: Intraoperative 0-70 minutes
measure: Median Post Anesthesia Care Unit Sublingual Temperature
timeFrame: Upon arrival to the post anesthesia care unit
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Enrico M Camporesi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
citation: Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.
citation: Taguchi A, Ratnaraj J, Kabon B, Sharma N, Lenhardt R, Sessler DI, Kurz A. Effects of a circulating-water garment and forced-air warming on body heat content and core temperature. Anesthesiology. 2004 May;100(5):1058-64. doi: 10.1097/00000542-200405000-00005.
citation: Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026.