Trial document





This trial has been registered retrospectively.
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  DRKS00005109

Trial Description

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Title

Unexpected high incidence of hypothermia before induction of anesthesia in elective surgical patients

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Trial Acronym

Preop Temp

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is a common phenomen that core temperature decreases below 36,0°C during and after surgery. For this reason core temperature will be analyzed before induction of anesthesia. Then patients below 36,0°C before anesthesia will be counted (=incidence) and patients below 36,0°C with those over 36,0°C will be compared to find risk factors. Sex, age, height, and weight will be collected. This study integrates data from seven prior studies of the University of Goettingen.

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Brief Summary in Scientific Language

Backround: Hypothermia (< 36,0C°) is a common side effect of anesthesia and is associated with adverse patient outcome.
Hypothesis: high incidence of hypothermia already before anesthesia and surgery.
Methods: Measuring core temperature before induction of anesthesia, including patients with elective surgeries. Potential risk factors will be documented.
Analysis: Analysis of incidence of hypothermia before induction of anesthesia and multivariate Analysis of potential risk factors of hypothermia before induction of anesthesia.

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Organizational Data

  •   DRKS00005109
  •   2013/11/15
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  •   yes
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Secondary IDs

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Health Condition or Problem studied

  •   Hypothermia
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Interventions/Observational Groups

  •   Backround: Hypothermia (< 36,0C°) is a common side effect of anesthesia and is associated with adverse patient outcome.
    Hypothesis: high incidence of hypothermia already before anesthesia and surgery.
    Methods: Measuring core temperature before induction of anesthesia, including patients with elective surgeries. Potential risk factors will be documented.
    Analysis: Analysis of incidence of hypothermia before induction of anesthesia and multivariate Analysis of potential risk factors of hypothermia before induction of anesthesia.
    Grouping of patients for Analysis:
    Group 1: > 36,0°C core temperature before induction of anesthesia
    Group 2 < 36,0°C before induction of anesthesia
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Icidence of Hypothermia
measured with Thermometer before induction of anesthesia

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Secondary Outcome

Median of core temperature calculated,
calculation and identification of risk factors: Age, weight, height, sex. Data is collected from the intraoperative anesthesia document. Further calculated risk factors: Body Mass Index, lean bofy weight, adipose Ratio.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   525
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

complete Data sets
elective surgery

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Exclusion Criteria

< 18 years, thyroid disease, pregnancy, ambulant surgery

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Ms.  Dr.  Anna  Wetz 
    • Robert-Kochstraße 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Ms.  Dr.  Anna  Wetz 
    • Robert-Kochstraße 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/02
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Trial Publications, Results and other Documents

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