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Evaluation of BARRIER® EasyWarm on Healthy Volunteers in Three Different Climates and Verification of the Degree of Correlation Between Tests Performed on Healthy Volunteers and in a standardized bench test

Kuklane, Kalev LU ; Gao, Chuansi LU ; Lundgren Kownacki, Karin LU ; Halder, Amitava LU ; Östberg, Magnus; Skintemo, Lisa; Grou, Anna; Törnqvist, Jens; Ganlöv, Karin and Åström, Mikael (2015) In Clinical Investigation Report PD-478190 Rev: 00.
Abstract
INTRODUCTION

Anaesthesia induced hypothermia is a common serious but preventable condition associated with increased bleeding and blood transfusion, increased risk for surgical site infections and increased risk for morbid cardiac events. Active warming is effective in preventing hypothermia but there is a need for more easy to use cost-effective products making active warming available to more patients. Establishing how the environment affects skin temperature and total body heat content (TBHC) as well as the correlation between standardized bench tests and healthy volunteer skin temperature is an important aspect in developing new, more effective warming products to prevent or treat hypothermia as this means fewer healthy... (More)
INTRODUCTION

Anaesthesia induced hypothermia is a common serious but preventable condition associated with increased bleeding and blood transfusion, increased risk for surgical site infections and increased risk for morbid cardiac events. Active warming is effective in preventing hypothermia but there is a need for more easy to use cost-effective products making active warming available to more patients. Establishing how the environment affects skin temperature and total body heat content (TBHC) as well as the correlation between standardized bench tests and healthy volunteer skin temperature is an important aspect in developing new, more effective warming products to prevent or treat hypothermia as this means fewer healthy volunteers are needed as changes to skin temperature could be estimated based on data from bench tests.



OBJECTIVES

This investigation was undertaken in order to investigate the safety and efficacy of Active warming with BARRIER® EasyWarm when used in three different climate settings and using different test methods; standardized bench test T-1127 measuring temperatures on a wooden board and measuring skin and core temperature on healthy volunteers. An additional objective in this investigation was to determine the degree of correlation between these test methods.



OUTCOME

A statistically significant increase in TBHC is seen when comparing TBHC over time in all three climates, respectively. With this investigation design we cannot show that there is a difference in TBHC between the different climates though, i.e. the heat generated from the blanket to the subject is not significantly different in the different climates. Based on this investigation the active warming blanket managed to maintain or increase the temperature of the subjects without any adverse thermal effects. Thermal comfort and the mean thermal sensation were maintained between slightly cold and warm throughout the whole exposure length.



The active self-warming blanket was well tolerated in healthy male volunteers. None of the six Adverse Events (AE) reported were serious and none of them were related to the investigational device but rather to the immobilisation or the tension of participating in the investigation. All AEs were resolved at end of test. Skin temperature reached maximally 42.2°C, and thus, it never reached the lowest pain threshold of 43°C under any conditions. Increase of core temperature over time in climate 18°C and 24°C was in average 0.1°C to 0.2°C leading to mean final core temperatures of 36.9 (SD 0.2) and 37.1 (SD 0.4) °C for 18°C and 24°C exposures, respectively. (Less)
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author
organization
publishing date
type
Book/Report
publication status
published
subject
in
Clinical Investigation Report
volume
PD-478190 Rev: 00
pages
68 pages
publisher
Mölnlycke Health Care, Gothenburg, Sweden
language
English
LU publication?
yes
id
c6ead4c4-6df7-4718-99c9-f055b242f06c (old id 4940805)
date added to LUP
2015-02-12 14:09:24
date last changed
2016-04-16 08:31:07
@techreport{c6ead4c4-6df7-4718-99c9-f055b242f06c,
  abstract     = {INTRODUCTION<br/><br>
Anaesthesia induced hypothermia is a common serious but preventable condition associated with increased bleeding and blood transfusion, increased risk for surgical site infections and increased risk for morbid cardiac events. Active warming is effective in preventing hypothermia but there is a need for more easy to use cost-effective products making active warming available to more patients. Establishing how the environment affects skin temperature and total body heat content (TBHC) as well as the correlation between standardized bench tests and healthy volunteer skin temperature is an important aspect in developing new, more effective warming products to prevent or treat hypothermia as this means fewer healthy volunteers are needed as changes to skin temperature could be estimated based on data from bench tests.<br/><br>
<br/><br>
OBJECTIVES<br/><br>
This investigation was undertaken in order to investigate the safety and efficacy of Active warming with BARRIER® EasyWarm when used in three different climate settings and using different test methods; standardized bench test T-1127 measuring temperatures on a wooden board and measuring skin and core temperature on healthy volunteers. An additional objective in this investigation was to determine the degree of correlation between these test methods.<br/><br>
<br/><br>
OUTCOME<br/><br>
A statistically significant increase in TBHC is seen when comparing TBHC over time in all three climates, respectively. With this investigation design we cannot show that there is a difference in TBHC between the different climates though, i.e. the heat generated from the blanket to the subject is not significantly different in the different climates. Based on this investigation the active warming blanket managed to maintain or increase the temperature of the subjects without any adverse thermal effects. Thermal comfort and the mean thermal sensation were maintained between slightly cold and warm throughout the whole exposure length.<br/><br>
<br/><br>
The active self-warming blanket was well tolerated in healthy male volunteers. None of the six Adverse Events (AE) reported were serious and none of them were related to the investigational device but rather to the immobilisation or the tension of participating in the investigation. All AEs were resolved at end of test. Skin temperature reached maximally 42.2°C, and thus, it never reached the lowest pain threshold of 43°C under any conditions. Increase of core temperature over time in climate 18°C and 24°C was in average 0.1°C to 0.2°C leading to mean final core temperatures of 36.9 (SD 0.2) and 37.1 (SD 0.4) °C for 18°C and 24°C exposures, respectively.},
  author       = {Kuklane, Kalev and Gao, Chuansi and Lundgren Kownacki, Karin and Halder, Amitava and Östberg, Magnus and Skintemo, Lisa and Grou, Anna and Törnqvist, Jens and Ganlöv, Karin and Åström, Mikael},
  institution  = {Mölnlycke Health Care, Gothenburg, Sweden},
  language     = {eng},
  pages        = {68},
  series       = {Clinical Investigation Report},
  title        = {Evaluation of BARRIER® EasyWarm on Healthy Volunteers in Three Different Climates and Verification of the Degree of Correlation Between Tests Performed on Healthy Volunteers and in a standardized bench test},
  volume       = {PD-478190 Rev: 00},
  year         = {2015},
}