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| ID | Type | Description | Link |
|---|---|---|---|
| EA1/142/10 | Other Identifier | ethics commitee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thermal management with LMA PerfecTemp™ | Experimental |
| |
| no specific thermal management | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA Perfect Temp | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature at the end of the intervention | 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 | average 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| hospital stay | max 28 days | |
| mechanical ventilation time | The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Sander, MD | Dept. of Anesthesiology Charité Universitaetsmedizin Berlin | Principal Investigator |
| Claudia Spies, MD | Dept. of Anesthesiology Charité Universitaetsmedizin Berlin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| maximum 28 days |