Intraoperative Warming Comparison of Devices

Hypothermia Clinical Trial

Official title:

Intraoperative Warming : Comparison of Performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650260
• Other study ID #: IRB 106411c
• Secondary ID: TGH 100USF 6176-
• Status: Completed
• Phase: N/A
• First received: March 27, 2008
• Last updated: September 25, 2012
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2012
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Dynatherm Medical vitalHEAT Temperature Management System vH2
The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical.
• Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
The Bair Hugger system is the current standard of care at Tampa General Hospital. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket.

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Dynatherm Medical Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. — View Citation

Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. Review. — View Citation

Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius		Intraoperative Period	Yes
Primary	Percent of Subjects With an Initial PACU Sublingual Temperature of = 36º C.		Temp taken just prior to surgery	Yes
Primary	Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius	Percent of subjects with an initial post anesthesia care unit sublingual temperature of = 36º C	Upon entry to the post anesthesia care unit	No
Secondary	Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.	Average core body temperature measured with an esophageal probe at 60 minutes post-induction	60 minutes post anesthesia induction	No
Secondary	Average Intraoperative Esophageal Temperature	Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.	Intraoperative 0-70 minutes	No
Secondary	Median Post Anesthesia Care Unit Sublingual Temperature		Upon arrival to the post anesthesia care unit	Yes