Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Conditions
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Outcomes, Body Temperature

Intervention / Treatment
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* Device: LMA Perfect Temp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thermal management with LMA PerfecTemp™<br> | Device: LMA Perfect Temp<br>* 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<br>|
| Active Comparator: no specific thermal management<br> | Device: LMA Perfect Temp<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | maximum 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, minimal invasive valve replacement