An interventional study of LMA Perfect Temp in Outcomes and Body Temperature, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-19.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Supportive care
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.
Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: LMA Perfect Temp
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
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
Time frame: average 2 hours
hospital stay
Time frame: 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.
Time frame: maximum 28 days
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Charite University, Berlin, Germany