Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

NCT01176110 | Completed DMC

• 2 other identifiers: TIMI101EA1/142/10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Outcomes; Body Temperature

Keywords

hypothermia; minimal invasive valve replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• hospital stay

  max 28 days

• mechanical ventilation time

  maximum 28 days

Study Arms (2)

thermal management with LMA PerfecTemp™

EXPERIMENTAL

Device: LMA Perfect Temp

no specific thermal management

ACTIVE COMPARATOR

Device: LMA Perfect Temp

Interventions

LMA Perfect Temp DEVICE

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; thermal management with LMA PerfecTemp™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Sander, MD

  Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Claudia Spies, MD

  Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 5, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2010-07

Locations

DE (1)