Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement (TIMI)
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About
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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