Body Temperature, Outcomes
Conditions
Keywords
hypothermia, minimal invasive valve replacement
Brief summary
It is known that perioperative hypothermia can influence the postoperative outcome negatively. The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound infection rate. The thermal redistribution after the induction of anesthesia is on of the reasons for perioperative hypothermia. Another reason is negative heat balance during surgery. Further negative side effects of hypothermia are an increase of blood viscosity and thus a higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding. The aim of the study is to evaluate if patients with a perioperative active thermal management during an interventional minimal invasive valve replacement have a significantly higher body temperature at the end of the operation than patients without an active thermal management. Secondary outcome variables are complication rates, length of mechanical ventilation and length of ICU treatment.
Interventions
DEVICELMA Perfect Temp
The LMA PerfecTemp™ patient warming system combines warming beneath the patient and advanced pressure reduction to combat hypothermia and decubitus ulcers. This device is used during the interventional minimal invasive valve replacement with unprecedented ease and safety
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients, who need an interventional minimal invasive valve replacement * Age ≥ 18 years * scheduled general anesthesia during intervention * no participation on another interventional study * signed informed consent
Exclusion criteria
* pregnant or breast feeding women * non-elective intervention * conversion to HLM * implantation of IABP * pre-existing decubitus * patients who are not able to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature at the end of the intervention | average 2 hours | The end of the surgical procedure is defined and is recorded for all patients in the hospital information systems. This time point will be used to record the body temperature at the end of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospital stay | max 28 days | — |
| mechanical ventilation time | maximum 28 days | The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study. |
Countries
Germany
Outcome results
None listed