OutcomesTIMINCT01176110
Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
A study testing LMA Perfect Temp in people with Outcomes and Body Temperature, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcomes, Body Temperature
- What is being tested?
- LMA Perfect Temp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, State of Berlin, 10117
About this study
Official title: A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
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.
Read more
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
- Being tested
- LMA Perfect Temp
- Keywords
- hypothermia, minimal invasive valve replacement
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA Perfect TempDevice
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
| Study group | Role | What they receive |
|---|---|---|
| thermal management with LMA PerfecTemp™ | Experimental | Not described Receives: Device: LMA Perfect Temp |
| no specific thermal management | Active comparator | Not described Receives: Device: LMA Perfect Temp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: average 2 hours
Secondary outcomes (2)
hospital stay
Measured: max 28 days
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.
Measured: maximum 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Michael Sander, MD, Principal investigator, Dept. of Anesthesiology Charité Universitaetsmedizin BerlinClaudia Spies, MD, Study chair, Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176110
- Sponsor's protocol ID
- TIMI101
- Other IDs
- EA1/142/10
- Acronym
- TIMI
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement
- ClinicalTrials.gov ID
- NCT01176110
- Acronym / sponsor ID
- TIMI / TIMI101
- Conditions
- Outcomes, Body Temperature
- Keywords
- hypothermia, minimal invasive valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thermal management with LMA PerfecTemp™ | Experimental | Device: LMA Perfect Temp |
| no specific thermal management | Active comparator | Device: LMA Perfect Temp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- pregnant or breast feeding women
- non-elective intervention
- conversion to HLM
- implantation of IABP
- pre-existing decubitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA Perfect TempThe 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 | Device | no specific thermal management, thermal management with LMA PerfecTemp™ |
Primary outcome
Temperature at the end of the intervention
Time frame: 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
2 secondary outcomes
hospital stay
Time frame: max 28 days
mechanical ventilation time
Time frame: maximum 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sander, MD principal investigator
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Claudia Spies, MD study chair
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA Perfect Temp in people with Outcomes and Body Temperature, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature at the end of the intervention (time frame: average 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.