Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.
What Are Reference Values of the Thickness and the Thickening Fraction of the Diaphragm in Children Aged 0-8 Years?
1 other identifier
interventional
120
1 country
1
Brief Summary
Critically ill children treated with invasive mechanical ventilation (iMV) in a paediatric intensive care unit (PICU) may suffer from complications leading to prolonged duration of ventilation and PICU stay. Prolonged ventilation is associated with haemodynamic dysfunction, neuromuscular insufficiency, malnutrition, metabolic disorders and diaphragmatic muscle weakness. Evidence from adult critical care supports the existence of ventilator induced diaphragmatic dysfunction, defined as a iMV-induced loss of diaphragmatic force - generating capacity - characterised by muscle fibre atrophy, myofibril necrosis and disorganization. Diaphragm function or contractility can be assessed by measuring the diaphragm thickening during inspiration and expiration with ultrasound and is expressed as a thickening fraction (TF). A low diaphragm contractile activity in adults has been associated with rapid decreases in diaphragm thickness, whereas high contractile activity has been associated with increases in diaphragm thickness. Contractile activity decreased with increasing ventilator driving pressure and controlled ventilator mode. Maximal thickening fraction (a measure of diaphragm function) was lower in patients with decreased as well as increased diaphragm thickness than in patients with unchanged thickness (p=0.05). Titrating ventilatory support to maintain normal levels of inspiratory effort may prevent changes in diaphragm configuration associated with iMV, but more research is needed to confirm this supposition. Only one study has shown the presence of diaphragm atrophy in critically ill children on iMV for acute respiratory failure. The diaphragm contractility, measured as thickening fraction, was strongly correlated with a spontaneous breathing fraction. Norm data for diaphragmatic thickness and TF in children are only available for healthy neonates (n=15) and children (n=48) from 8 till 20 years of age. The purpose of this study is to determine values of normal diaphragm thickness and TF in children aged 0-8 years by ultrasound. This age range reflects the largest patient group treated in the PICU. Once these values are known, the clinical relevance of the measuring of the diaphragm thickness of ventilated children by ultrasound can be further studied. Objective of the study: Primary objective: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary objective: To determine the interrater reliability of operators performing the ultra-sound Study design: prospective, cohort study. Study population: Healthy children in four age groups: 0-6 months; 6 months-1 year; 2-4 years; and 5-8 years. Participants will be recruited in two ways: Group 1. Parents of children scheduled to undergo a daycare procedure will asked permission for their child to join the study. These children undergo a minor procedure and are assumed to have a normal diaphragm; therefore are considered 'healthy''. Group 2. Health professionals working on the PICU or other departments of Erasmus MC-Sophia as well as family, friends and neighbours of members of the research group will be asked to recruit 'healthy' children. The investigators will recruit participants by means of brochures in which children and/or caregivers are invited to contact the researchers when interested to participate in this study. Primary study parameters/outcome of the study: To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age. Secondary study parameters/outcome of the study (if applicable): To determine the interrater reliability of operators performing the ultra-sound
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedAugust 12, 2022
August 1, 2022
8 months
October 9, 2020
August 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
diaphragm thickness
To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age.
Day 1
Secondary Outcomes (1)
Interrater reliability
During 6 months
Study Arms (1)
Ultra-sound arm
OTHERUltrasound measurement of the diaphragm will be performed with the use of a Sono Site SII, portable system in B mode with the child in a 30-degree supine position. The diaphragm thickness will be measured with a high frequency (4-10 MHz) linear array transducer placed in the ninth or tenth intercostal space between the anterior and midaxillary lines in the zone of apposition between lung and liver.
Interventions
Ultrasound measurement of the diaphragm will be performed with the use of a Sono Site SII, portable system in B mode with the child in a 30-degree supine position. The diaphragm thickness will be measured with a high frequency (4-10 MHz) linear array transducer placed in the ninth or tenth intercostal space between the anterior and midaxillary lines in the zone of apposition between lung and liver.
Eligibility Criteria
You may qualify if:
- Group 1
- Children aged 0-8 years old undergoing one of the following daycare procedures:
- Surgery: inguinal hernia and umbilical hernia surgery
- Urology: hypospadias surgery
- Throat/nose/ear surgery: tympanostomy tubes, removal of throat and nasal tonsils
- Orthopedics: congenital club feet surgery, hip luxation surgery, removing pins
- Plastic surgery: protruding ears surgery, removing of accessory auricle, removing additional toes and fingers - Ophthalmology: cataract and strabismus surgery
- Immunology: infusion therapy: e.g. prophylaxis of immunoglobulins
- Group 2
- Children aged 0-8 years old recruited by colleagues, or relatives, friends and neighbours of members of the research group
You may not qualify if:
- Neuromuscular diseases
- Lung diseases
- Recent abdominal or thoracic surgery (less than 3 month ago) - Deviations of the diaphragm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus MC-Sophia Children's Hospital
Rotterdam, 3015GD, Netherlands
Related Publications (1)
Duyndam A, Smit J, Heunks L, Molinger J, IJland M, van Rosmalen J, van Dijk M, Tibboel D, Ista E. Reference values of diaphragmatic dimensions in healthy children aged 0-8 years. Eur J Pediatr. 2023 Jun;182(6):2577-2589. doi: 10.1007/s00431-023-04920-6. Epub 2023 Mar 20.
PMID: 36939879DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Associate professor nursing science
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 19, 2020
Study Start
September 1, 2020
Primary Completion
May 1, 2021
Study Completion
August 1, 2021
Last Updated
August 12, 2022
Record last verified: 2022-08