Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
NCT ID: NCT01176110
Last Updated: 2011-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2010-07-31
2011-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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thermal management with LMA PerfecTemp™
LMA 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
no specific thermal management
LMA 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
Interventions
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LMA 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
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* scheduled general anesthesia during intervention
* no participation on another interventional study
* signed informed consent
Exclusion Criteria
* non-elective intervention
* conversion to HLM
* implantation of IABP
* pre-existing decubitus
* patients who are not able to sign informed consent
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Charité - Universitätsmedizin Berlin
Principal Investigators
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Michael Sander, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Claudia Spies, MD
Role: STUDY_CHAIR
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Locations
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Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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EA1/142/10
Identifier Type: OTHER
Identifier Source: secondary_id
TIMI101
Identifier Type: -
Identifier Source: org_study_id
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