Trial document




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  DRKS00004200

Trial Description

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Title

Comparison of a patient warming system using a forced-air, non-compressible under-body mattress versus a regular forced-air underbody mattress system during surgery in pediatrics

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Trial Acronym

Bair Hugger Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

During an operation the body cools down very quickly. Temperature reduction is an important regulatory mechanisms in the body, for example changings in the coagulation systems. Most warming problems are intraoperativ in small children. So we will evaluate children until the age of two years.
Over the years, many heating systems are designed to regulate temperature intraoperative.
The hypothesis of this study is to evaluate the efficience of this two warming systems ( Bair Hugger versus Möck Warming system)

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Brief Summary in Scientific Language

Perioperative hypothermia during major abdominal and orthopaedic surgery is a common problem challenging the anaesthesiologist. It is caused by the inhibition of thermoregulation induced by anaesthesia, redistribution of body heat from the core to the periphery and the exposure of patients’ skin and tissues to a cold environment in the operation theatre.
Mild hypothermia decreases the activation of the coagulation cascade and reduces platelet function. Consistent with these in vitro data it was shown that perioperative hypothermia increases bleeding and blood transfusion requirements.
A decreasing in core hypothermia of just 1.5°C triples the incidence of morbid cardiac complications and ventricular tachycardia .
The metabolism of most anaesthetic drugs, including muscle relaxants and propofol is significantly decreased . This explains the observation that mild hypothermia significantly prolongs the postoperative recovery period (even if temperature is not a discharge criterion) .
Approximately 40% of unwarmed patients after general anaesthesia suffer from shivering, which is accompanied by significant adrenergic activation and discomfort. Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market. However, forced air warming may be disadvantageous, if the only warming available is the patient’s back, as is commonly the case in pediatric surgery.
We will compare a non-compressible, underbody mattress system (Baby/Kleinkinddecke des MoeckWarmingSystems, art. 902, Moeck und Moeck GmbH, Hamburg, Germany; using Moeck und Moeck Twinwarm forced air blower) with the established warming system, which blows warm air via a compressible matress over the body of the pediatric patients (Pediatric Underbody, BairHugger, Arizant, MN, USA; forced air blower: BairHugger model # 750).

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Organizational Data

  •   DRKS00004200
  •   2012/07/13
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  •   yes
  •   Approved
  •   1270/2012, Ethikkommission der Medizinischen Universität Wien Borschkegasse 8B/E06 1090 Wien
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Secondary IDs

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Health Condition or Problem studied

  •   T68 -  Hypothermia
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Interventions/Observational Groups

  •   40 patients warmed by warming system "bair hugger" (compressible matress)
  •   40 patients warmed with moeck Air warming system (non-compressible mattress system)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

80 patients are warmed by 2 different warming systems intraoperatively and measured continous with 4skin electrodes and 1 core temperature electrode.

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Secondary Outcome

Differences in skin changes are clinical (visual) evaluated postoperatively

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/24
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   5   Years
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Additional Inclusion Criteria

- children undergoing surgery
- children with a weight under 18kg

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Exclusion Criteria

- Patienst under therapeutic hypothermia
- fever

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Addresses

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    • Anästhesie, Allgemiene Intensivmedizin und Schmerztherapie
    • Mr.  Univ.- Prof. Dr.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien
    • Ms.  Dr.med.univ  Lydia  Triffterer 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien
    • Ms.  Dr.med.univ  Lydia  Triffterer 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    • Mr.  Univ.Prof.Dr.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/11
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Trial Publications, Results and other Documents

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