NCT01176110

Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Outcomes
• Body Temperature

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2010-08-05
• Last updated: 2011-05-19

Locations

1 site across 1 country: Germany