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Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

NCT01176110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Michael Sander, MD · Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

  • Claudia Spies, MD · Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176110 on ClinicalTrials.gov