Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement (TIMI)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01176110
First received: July 29, 2010
Last updated: May 18, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention
Outcomes
Body Temperature
Device: LMA Perfect Temp

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Temperature at the end of the intervention [ Time Frame: average 2 hours ] [ Designated as safety issue: Yes ]
    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:
  • hospital stay [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
  • mechanical ventilation time [ Time Frame: maximum 28 days ] [ Designated as safety issue: No ]
    The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study.


Estimated Enrollment: 40
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: thermal management with LMA PerfecTemp™ 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
Active Comparator: no specific thermal management 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176110

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Michael Sander, MD Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Study Chair: Claudia Spies, MD Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
  More Information

No publications provided

Responsible Party: PD Dr. Michael Sander, Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Charité - Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT01176110     History of Changes
Other Study ID Numbers: TIMI101, EA1/142/10
Study First Received: July 29, 2010
Last Updated: May 18, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
hypothermia
minimal invasive valve replacement

ClinicalTrials.gov processed this record on September 30, 2014