Intraoperative Warming Comparison of Devices

This study has been completed.
Sponsor:
Collaborator:
Dynatherm Medical Inc.
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida
ClinicalTrials.gov Identifier:
NCT00650260
First received: March 27, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Hypothermia
Device: Dynatherm Medical vitalHEAT Temperature Management System vH2
Device: Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intraoperative Warming : Comparison of Performance of the Dynatherm Medical vitalHEAT™ Temperature Management System (vH2) and the Arizant Bair Hugger System

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius [ Time Frame: Intraoperative Period ] [ Designated as safety issue: Yes ]
  • Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C. [ Time Frame: Temp taken just prior to surgery ] [ Designated as safety issue: Yes ]
  • Percentage of Patients With a Post Operative Sublingual Temperature Above 36 Degrees Celcius [ Time Frame: Upon entry to the post anesthesia care unit ] [ Designated as safety issue: No ]
    Percent of subjects with an initial post anesthesia care unit sublingual temperature of ≥ 36º C


Secondary Outcome Measures:
  • Comparison of the Core Body Temperatures at 60 Minutes Post Anesthesia Induction,as Assessed by Esophageal Probe. [ Time Frame: 60 minutes post anesthesia induction ] [ Designated as safety issue: No ]
    Average core body temperature measured with an esophageal probe at 60 minutes post-induction

  • Average Intraoperative Esophageal Temperature [ Time Frame: Intraoperative 0-70 minutes ] [ Designated as safety issue: No ]
    Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia.

  • Median Post Anesthesia Care Unit Sublingual Temperature [ Time Frame: Upon arrival to the post anesthesia care unit ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vH2 System Group
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
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.
Other Name: Part number VH-200
Active Comparator: Control Group
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)
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.
Other Name: Model 522

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00650260

Locations
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Dynatherm Medical Inc.
Investigators
Principal Investigator: Enrico M Camporesi, M.D. University of South Florida
  More Information

Publications:
Responsible Party: Enrico Camporesi, Emeritus Professor of Surgery / Anesthesiology, University of South Florida
ClinicalTrials.gov Identifier: NCT00650260     History of Changes
Other Study ID Numbers: IRB 106411c, TGH 100, USF 6176-P67639
Study First Received: March 27, 2008
Results First Received: August 5, 2010
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
intraoperative warming
anesthesia
hypothermia
body temperature

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014