Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Intraoperative Warming Comparison of Two Temperature Management Systems
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intraoperative Warming Comparison of Performance of the AVAcore Technologies WarmUP Temperature Management System WU-20 and the Arizant Bair Hugger Temperature Management System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare two temperature management systems the warmUP WU-20 and the Bair Hugger in preventing perioperative hypothermia during surgeries The study aims to determine whether the warmUP system is as effective as the Bair Hugger in maintaining core body temperature
The main questions this trial aims to answer are
Does the warmUP system maintain intraoperative body temperatures as effectively as the Bair Hugger during abdominal surgeries
Does the warmUP system offer additional benefits such as reduced bacterial dispersion compared to the Bair Hugger
Participants will
Use either the warmUP or Bair Hugger system during surgery Undergo abdominal surgeries lasting approximately 25 hours Have their core temperatures monitored to assess the effectiveness of the warming device
The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed potentially offering advantages in surgical infection control
The main questions this trial aims to answer are
Does the warmUP system maintain intraoperative body temperatures as effectively as the Bair Hugger during abdominal surgeries
Does the warmUP system offer additional benefits such as reduced bacterial dispersion compared to the Bair Hugger
Participants will
Use either the warmUP or Bair Hugger system during surgery Undergo abdominal surgeries lasting approximately 25 hours Have their core temperatures monitored to assess the effectiveness of the warming device
The study will evaluate whether the warmUP system provides equivalent temperature management with a smaller body surface area exposed potentially offering advantages in surgical infection control
Detailed Description:
Mild perioperative hypothermia core temperature 34-36ºC occurs commonly during anesthesia and surgery as a result of a combination of factors anesthetic induced impairment of thermoregulatory controls internal redistribution of heat within the body surgical site skin preparation and subsequent exposure to the cold OR environment Induction of general anesthesia causes marked changes in the distribution of body heat between the patients core and periphery An initial drop in core temperature of between 05 to 15ºC after induction is the result of internal core-to-periphery redistribution of body heat caused by a combination of anesthesia induced vasodilation and decreased thermoregulatory vasoconstriction Continued thermal imbalance during anesthesia results from inability of metabolic heat production to overcome the heat loss
The complications related to mild perioperative hypothermia have been documented in numerous studies and summarized in a 1999 article Maintaining intraoperative normothermia a meta-analysis of outcomes with costs Complications include reduced resistance to surgical wound infection reduced platelet function increased intraoperative loss of blood increased incidence of ventricular tachycardia and morbid cardiac events Additionally the duration of postoperative recovery has also been shown to be prolonged by mild hypothermia
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 However during certain surgical procedures such as laparatomy a large section of the skin surface ie abdomen and part of the patient in contact with the OR table is unavailable This can limit the efficacy of methods such as forced-air warming which rely on a large skin surface for heat transfer Thus one criterion for an alternative non-invasive warming device is that the heat generated by that device reach its desired target in the case of perioperative hypothermia that target is the patients thermal coreGrahn et al determined that it would be feasible to combine subatmospheric pressure with a thermal load heat and then apply this combination to the bodys own specialized heat transfer areas - the ArterioVenous Anastamoses AVAs -- found in the hands and the feet By mechanically distending these specialized heat exchange vessels the AVAs through the application of negative pressure heat can be transferred more efficiently to the body core
AVAcore Technologiess warmUP WU-20 Temperature Management System was developed based on work with the Aquarius Medical Acrotherm device reference 510k number K003368 and prior human hypothermic subject data showing a rewarming rate of 1ºC in 5 minutes when heat and vacuum application was tested AVAcore Technologies received FDA acceptance of its Section 510k premarket notification for the warmUP vH1 Temperature Management System in 2005 reference 510k number K040911 This product was used on over 100 patients in the US in 2005-2006 timeframe
The warmUP WU-20 Temperature Management System proposed for use in this study is a minor modification to the vH1 System The warmUP WU-20 Temperature Management System is a released product covered with a Letter to File per an assessment based on FDA Guidance documents The Arizant Healthcare Bair Hugger Temperature Management System proposed for use in this study is a forced air system providing convective warming via the circulation of warmed air through a specially designed blanket which is placed over a portion of the patients body This system has FDA acceptance reference 510k number K021473 This product has been in use in the US for over 20 years in a majority of hospitals
The primary objective is to determine if the AVAcore Technologies warmUP WU-20 Temperature Management System is as effective as forcedair 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 PACU 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 PACU temperature trends and hypothermic symptoms such as shivering
The complications related to mild perioperative hypothermia have been documented in numerous studies and summarized in a 1999 article Maintaining intraoperative normothermia a meta-analysis of outcomes with costs Complications include reduced resistance to surgical wound infection reduced platelet function increased intraoperative loss of blood increased incidence of ventricular tachycardia and morbid cardiac events Additionally the duration of postoperative recovery has also been shown to be prolonged by mild hypothermia
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 However during certain surgical procedures such as laparatomy a large section of the skin surface ie abdomen and part of the patient in contact with the OR table is unavailable This can limit the efficacy of methods such as forced-air warming which rely on a large skin surface for heat transfer Thus one criterion for an alternative non-invasive warming device is that the heat generated by that device reach its desired target in the case of perioperative hypothermia that target is the patients thermal coreGrahn et al determined that it would be feasible to combine subatmospheric pressure with a thermal load heat and then apply this combination to the bodys own specialized heat transfer areas - the ArterioVenous Anastamoses AVAs -- found in the hands and the feet By mechanically distending these specialized heat exchange vessels the AVAs through the application of negative pressure heat can be transferred more efficiently to the body core
AVAcore Technologiess warmUP WU-20 Temperature Management System was developed based on work with the Aquarius Medical Acrotherm device reference 510k number K003368 and prior human hypothermic subject data showing a rewarming rate of 1ºC in 5 minutes when heat and vacuum application was tested AVAcore Technologies received FDA acceptance of its Section 510k premarket notification for the warmUP vH1 Temperature Management System in 2005 reference 510k number K040911 This product was used on over 100 patients in the US in 2005-2006 timeframe
The warmUP WU-20 Temperature Management System proposed for use in this study is a minor modification to the vH1 System The warmUP WU-20 Temperature Management System is a released product covered with a Letter to File per an assessment based on FDA Guidance documents The Arizant Healthcare Bair Hugger Temperature Management System proposed for use in this study is a forced air system providing convective warming via the circulation of warmed air through a specially designed blanket which is placed over a portion of the patients body This system has FDA acceptance reference 510k number K021473 This product has been in use in the US for over 20 years in a majority of hospitals
The primary objective is to determine if the AVAcore Technologies warmUP WU-20 Temperature Management System is as effective as forcedair 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 PACU 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 PACU temperature trends and hypothermic symptoms such as shivering
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None