Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06342726 |
| Other study ID # |
2024/714469 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2024 |
| Est. completion date |
June 2, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Haukeland University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this study, we aim to compare the effect of active external rewarming to passive rewarming
in healthy research participants on core temperature.
The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2
different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active
rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine.
Description:
Accidental hypothermia is defined as an involuntary drop in core body temperature below 35°C.
Hypothermia is a risk factor for cardiac arrythmia, pulmonary oedema, coagulopathy and
neurological pathology. Isolated accidental hypothermia is potentially lethal on its own, and
it is also an independent risk factor for increased mortality in patients with traumatic
injury.
When core temperature drops, the body will automatically activate compensatory mechanisms in
order to both increase thermic production and minimize heat loss in order to restore normal
temperature. The mechanisms for thermal homeostasis are complex, strictly regulated and
effective.
Until quite recently, active external rewarming was considered to be harmful and dangerous
for patients with accidental hypothermia. A fear of fatal complications such as increased
afterdrop and "rearming syndrome" leading to dangerous arrythmias and a drop in blood
pressure which in a worst case scenario could lead to circulatory collapse, shock and
potentially death.
Given the potentially detrimental consequences of being cold, any advice to abstain from
warming patients should be well-documented, and the adverse effects of warming should
outweigh those of being hypothermic. The lack of evidence for this claim that active external
rewarming is dangerous along with many reports of successful external rewarming is leading to
a change in most guidelines where active external rewarming is now an advisable treatment
option.
A variety of different technological devices exist for the purpose of rewarming, but there is
no established standard which is proven superior to others. Several trials have compared
different rewarming methods, but evidence is limited. There is particularly deficient
evidence regarding the amount of heat available for transfer from different methods and also
the required amount of heat transfer for the rewarming to have a significant clinical impact.
Given the relatively short time in which active external rewarming has been advised, we
suspect there is still a huge amount of room for improvement of care and technological
innovation.
There is however reason to be cautious with active external rewarming of hypothermic
patients. In a normothermic patient with normal circulatory function, thermal energy will be
absorbed by the blood which flows back into central circulation distributing the heat evenly
into a large volume. In a hypothermic patient there will be less cutaneous blood flow and
less heat will be transferred to systemic circulation. This means that heat will accumulate
on the skin surface and increase the risk of cutaneous injury, and there are several reported
cases of this.
Hypothermia research with volunteer research participants is a complicated matter for many
reasons. One complicating factor is shivering, which is an autonomic defense mechanism in
which the muscles contract rapidly producing heat. It is the most effective method for the
body to increase the metabolic heat production and re-establish normothermia. The shivering
response is complicated in a research setting because there is a large interindividual
variation in temperature threshold for initiation of shivering and in shivering intensity.
This means that if you cool research participants down they will start to shiver at different
core temperatures and with different intensities. Standardization of data is therefore
impossible, and the researcher will be measuring the interindividual shivering abilities of
the different research participants instead of the effect of the intervention. Shivering must
therefore be inhibited in order to achieve reliable data.
