Intraoperative Warming Comparison of Devices

NCT00650260 | Completed Results

• 3 other identifiers: IRB 106411cTGH 100USF 6176-P67639
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Keywords

intraoperative warming; anesthesia; hypothermia; body temperature

Outcome Measures

Primary Outcomes (3)

• Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius

  Intraoperative Period

• Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C.

  Temp taken just prior to surgery

• 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

Secondary Outcomes (3)

• Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe.

  60 minutes post anesthesia induction

• Average Intraoperative Esophageal Temperature

  Intraoperative 0-70 minutes

• Median Post Anesthesia Care Unit Sublingual Temperature

  Upon arrival to the post anesthesia care unit

Study Arms (2)

vH2 System Group

EXPERIMENTAL

The vital heat 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. The vital heat vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.

Device: Dynatherm Medical vitalHEAT Temperature Management System vH2

Control Group

ACTIVE COMPARATOR

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. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.

Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)

Interventions

Dynatherm Medical vitalHEAT Temperature Management System vH2 DEVICE

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.

Also known as: Part number VH-200

vH2 System Group

Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN) DEVICE

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.

Also known as: Model 522

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Dynatherm Medical Inc.: collaborator

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (4)

• 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.

  PMID: 17342966 BACKGROUND

• Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042.

  PMID: 10691247 BACKGROUND

• 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.

  PMID: 15114200 BACKGROUND

• 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.

  PMID: 8141463 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Enrico Camporesi MD
• Organization: University of South Florida Dept of Surgery/Anesthesiology

ecampore@health.usf.edu

813-844-7170

Study Officials

• Enrico M Camporesi, M.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Surgery / Anesthesiology

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 29, 2012
• Results First Posted: October 29, 2012

Record last verified: 2012-09

Locations

US (1)