Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03273894 |
| Other study ID # |
Temperature KDAR 2017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
February 24, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Brno University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Perioperative hypothermia carries high risk of associated complications. In the observational
study, the standard perioperative temperature management will be evaluated and the influence
of the hypothermia on the coagulation system according to routine coagulation testing in
combination with ROTEM will be evaluated.
Description:
Perioperative hypothermia is one of the complications of surgical interventions in total or
regional anaesthesia. It is defined as a drop in body core temperature under 36°C. It occurs
as a result of combination of anaesthesia, effecting of central thermoregulation control,
environment temperature (i.e. operating theatre) and unsufficient isolation combined with
patient's unability to actively warm up. As the body temperature drop in patients under
anaesthesia is very frequent, body temperature checks became part of surgical patients care
optimalisation. Furthermore, it is associated with complications, such as higher incidency of
surgical wound infection, elongated healing process, longer time spent in a hospital, cardiac
complications, elongated effect of most of anaesthetics, immunity and blood clotting
disorders. Hypothermia elongates the initial phase of coagulation and results in thrombocytes
malfunction. Normothermia reduces blood loss.
This prospective observative study has two parts. In the first one, investigators will
evaluate the perioperative management of temperature in paediatric patients in Department of
children anaesthesia and intensive care, University hospital Brno, Czech republic, where is
intended to involve 1,000 patients. In the second phase, the patients who, based on the first
phase of the study, would be the most prone to perioperative hypothermia, will be examined
for any change of coagulation parameters related to the hypothermia. Investigators intend to
involve 100 consecutive patients of the original group. The examined parameters are standard
coagulation tests, EXTEM, FIBTEM tests obtained from a rotational thromboelastometry, or
other ROTEM test related to the particular pathology. Investigators will use a standardized
method of fluid management to affect dilutional coagulopathy.
Standard perioperative patient's monitoring - temperature sensor monitoring of body
temperature, ECG, noninvasive blood pressure, oxygen saturation, EtCO2
Temperature management:
- the anaesthetist decides if some warming tools are needed and notes the used ones, which
involve: warmed infusion, heating blanked, air warming system, infusion pipe heater,
increasing of temperature in the operating theatre, covering the patient or another method of
temperature management
Monitored parameters in the first phase:
- body temperature before the intervention (measured in the office previously), operating
theatre's temperature at the beginning of anaesthesia
- body temperature during the intervention including the way of measuring, marked each 15
minutes
- body temperature at the end of the entire intervention, including signs of the patient's
heat discomfort
- body temperature during resting time in the after-surgery resting room
Monitored parameters in the second phase:
- monitored parameters in the first phase + following:
- blood sampling for standard coagulation tests (following initial of general anaesthesia)
+ EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant test are run.
The test is analysed by anaesthetist or ICU doctor, where the ROTEM machine is.
- blood sampling for standard coagulation tests (prior to the end of the surgical
intervention) + EXTEM, FIBTEM, NATEM. In case of any pathology found here, more relevant
test are run. The test is analysed by anaesthetist or ICU doctor, where the ROTEM
machine is.
- if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's
body temperature, following by another one at a standard temperature (37°C).
Statistic evaluation:
- demographic - age, sex, type of surgery, duration of surgery, type of anaesthesia
- changes of core temperature during the perioperative care and influence of used warming
tools, side effects of changes of core temperature
- laboratory tests - standard coagulation tests and ROTEM - EXTEM, FIBTEM, NATEM test
