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| ID | Type | Description | Link |
|---|---|---|---|
| TGH 100 | |||
| USF 6176-P67639 |
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| Name | Class |
|---|---|
| Dynatherm Medical Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Average Intraoperative Esophageal Temperature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrico M Camporesi, M.D. | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17342966 | Background | 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. | |
| 10691247 | Background | Sessler DI. Perioperative heat balance. Anesthesiology. 2000 Feb;92(2):578-96. doi: 10.1097/00000542-200002000-00042. |
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Subjects were recruited as they arrived for a scheduled surgical procedure at Tampa General Hospital. Potential subjects were addressed in a private pre-operative room. The investigators or study designee evaluated the patients for the study by reviewing the inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | vH2 System Group | 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. The 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. |
| FG001 | Control Group | The Bair Hugger system is the current standard of care at TGH. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | vH2 System Group | 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. The 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients With an Average Intraoperative Temperature Greater Than or Equal to 36 Celcius | Posted | Number | percentage of participants | Intraoperative Period |
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Total number of participants at risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | vH2 System Group | 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. The 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrico Camporesi MD | University of South Florida Dept of Surgery/Anesthesiology | 813-844-7170 | ecampore@health.usf.edu |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia. |
| Intraoperative 0-70 minutes |
| Median Post Anesthesia Care Unit Sublingual Temperature | Upon arrival to the post anesthesia care unit |
| 15114200 | 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. |
| 8141463 | 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. |
| BG001 | Control Group | The Bair Hugger system is the current standard of care at TGH. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Group | The Bair Hugger system is the current standard of care at TGH. 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. |
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| 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 | Posted | Mean | Standard Deviation | degrees celcius | 60 minutes post anesthesia induction |
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| Secondary | Average Intraoperative Esophageal Temperature | Average esophageal temperature for the first 70 minutes of surgery following induction of anesthesia. | Posted | Mean | Full Range | Degrees Celcius | Intraoperative 0-70 minutes |
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| Secondary | Median Post Anesthesia Care Unit Sublingual Temperature | Posted | Median | Full Range | Degrees Celcius | Upon arrival to the post anesthesia care unit |
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| Primary | Percent of Subjects With an Initial PACU Sublingual Temperature of ≥ 36º C. | Per protocol, sample size calculations indicate that a total sample size of 42 patients will be necessary to evaluate the primary outcome at an adjusted alpha = 0.05 with 80% power. | Posted | Number | Percentage of participants | Temp taken just prior to surgery |
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| 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 | Posted | Number | Percentage of participants | Upon entry to the post anesthesia care unit |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Control Group | The Bair Hugger system is the current standard of care at TGH. 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. | 0 | 21 | 0 | 21 |
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