Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Outcomes Clinical Trial

— TIMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176110
• Other study ID #: TIMI101
• Secondary ID: EA1/142/10
• Status: Completed
• Phase: N/A
• First received: July 29, 2010
• Last updated: May 18, 2011
• Start date: July 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Body Temperature
• Outcomes

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	hospital stay		max 28 days	No
Secondary	mechanical ventilation time	The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study.	maximum 28 days	No