Trial document
DRKS00014973
Trial Description
Title
Ultrasound determination of chest wall thickness and width of the intercostal space in children
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.
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.
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
Secondary IDs
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Health Condition or Problem studied
- J93.9 - Pneumothorax, unspecified
Interventions/Observational Groups
- Ultrasound determination of chest wall thickness and width of the intercostal space in children
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
Primary Outcome
Correlation of age, height, weight and body-mass-index with chest wall thickness
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2019/02/15
- 300
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- 10 Years
Additional Inclusion Criteria
Pediatric surgery
Exclusion Criteria
Deformities of the chest wall
Addresses
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start of 1:1-Block address primary-sponsor
- Universitätsklinikum Mannheim
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
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- http://www.umm.de
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start of 1:1-Block address scientific-contact
- Klinik für Anästhesiologie und Operative Intensivmedizin
- Mr. Dr. Tom Terboven
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049-621-383-3021
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- tom.terboven at umm.de
- http://www.umm.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik für Anästhesiologie und Operative Intensivmedizin
- Mr. Dr. Tom Terboven
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049-621-383-3021
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- tom.terboven at umm.de
- http://www.umm.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Mannheim
- Theodor-Kutzer-Ufer 1-3
- 68167 Mannheim
- Germany
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- http://www.umm.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2020/04/16
Trial Publications, Results and other Documents
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