Trial document



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  DRKS00014973

Trial Description

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Title

Ultrasound determination of chest wall thickness and width of the intercostal space in children

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In chest injuries, in rare cases even spontaneously, there may be an accumulation of air between the chest wall and the lungs. This accumulation of air can hinder breathing as well as lead to circulatory failure and is therefore a life-threatening situation. In an emergency situation, this accumulation of air is often punctured from the outside, through the chest wall, with a needle and the air is emptied. The puncture with a needle can lead to injuries of structures in the chest. Knowledge of the thickness of the chest wall and the width of the intercostal space is important for the emergency physician in order to minimize the risk of the injuries mentioned. For children, there are no reliable findings/data available so far. The thickness of the thoracic wall and the width of the intercostal space in children under 10 years of age will be measured by ultrasound in order to estimate the mentioned values in different age groups.

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Brief Summary in Scientific Language

Decompression of a tension pneumothorax represents an immediately necessary and life-saving procedure in an emergency situation. For adults, there is sufficient data available on the thickness of the chest wall and the correlated probability of success of a needle puncture for decompression. These data are completely lacking for pediatric patients. The aim of the planned work is to measure the chest wall thickness and the width of the intercostal space using ultrasound at four locations (2nd ICR medioclavicular, 4th ICR anterior axillary line, on both sides). This will be done on children (0-10 years) who are planning to undergo surgery under general anaesthesia in pediatric surgery. The accuracy of the ultrasound examination will be validated on the basis of data collected by means of CT images. This should prove the reliability of the ultrasound measurements. In addition, an examination of the relationship between the expression of the variables collected and the age, height, weight and BMI of the children is carried out. The aim is to investigate which of these parameters correlates best with the thickness of the chest wall and the width of the intercostal space. The measurements are made after the anaesthetic has been administered and do not represent any additional burden or risk for the children. The additional time required for the measurements is approximately 2 minutes per child. In addition, the age of the children, height and weight are to be recorded. The data is collected anonymously.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014973
  •   2019/02/11
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  •   yes
  •   Approved
  •   2019-1121N, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   J93.9 -  Pneumothorax, unspecified
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Interventions/Observational Groups

  •   Ultrasound determination of chest wall thickness and width of the intercostal space in children
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Characteristics

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

Correlation of age, height, weight and body-mass-index with chest wall thickness

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Secondary Outcome

Correlation of age, height, weight and body-mass-index with width of the intercostal space

Correlation of ultrasound measurements and measurements in computed tomography

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/15
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   10   Years
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Additional Inclusion Criteria

Pediatric surgery

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Exclusion Criteria

Deformities of the chest wall

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Addresses

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Tom  Terboven 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.  Tom  Terboven 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/16
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.