Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement (TIMI)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 29, 2010 | ||||||||
| Last Updated Date | May 18, 2011 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01176110 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement | ||||||||
| Official Title ICMJE | A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | May 2011 | ||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01176110 | ||||||||
| Other Study ID Numbers ICMJE | TIMI101, EA1/142/10 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | PD Dr. Michael Sander, Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Charité - Universitätsmedizin Berlin | ||||||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Charite University, Berlin, Germany | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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