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Completed

NCT Number: NCT01176110

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.

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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Key information

Conditions

Outcomes Body Temperature Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMA Perfect Temp

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. hospital stay

    Time frame: max 28 days

  2. mechanical ventilation time

    Time frame: maximum 28 days

    The mechanical ventilation time in the hospital is recorded electronically. The time frame will be recorded as the outcome measure in this study.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: TIMI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2010
Registry last updated
May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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