Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Not Applicable

Completed

• Conditions: Outcomes; Body Temperature
• Interventions: Device: LMA Perfect Temp

• Registration Number: NCT01176110
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thermal management with LMA PerfecTemp™	LMA Perfect Temp	-
no specific thermal management	LMA Perfect Temp	-

Primary Outcome Measures

Name	Time	Method
Temperature at the end of the intervention	average 2 hours	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

Secondary Outcome Measures

Name	Time	Method
hospital stay	max 28 days
mechanical ventilation time	maximum 28 days	The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany