Mechanical Ventilation ComplicationNCT04589910
Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.
A study testing diaphragm thickness and thickening fraction in people with Mechanical Ventilation Complication and Pediatric ALL, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication, Pediatric ALL, Intensive Care Unit Acquired Weakness
- What is being tested?
- diaphragm thickness and thickening fraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Neuromuscular diseases
- Lung diseases
- Recent abdominal or thoracic surgery (less than 3 month ago) - Deviations of the diaphragm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are Reference Values of the Thickness and the Thickening Fraction of the Diaphragm in Children Aged 0-8 Years?
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).
Read more
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
- Being tested
- diaphragm thickness and thickening fraction
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm thickness and thickening fractionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-sound arm | Other | 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. Receives: Diagnostic Test: diaphragm thickness and thickening fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm thickness
To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age.
Measured: Day 1
Secondary outcomes (1)
Interrater reliability
Interrater reliability of operators performing the ultra-sound
Measured: During 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erwin Ista, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589910
- Sponsor's protocol ID
- NL70476.078.19
- Status last verified
- Aug 2022
- First submitted
- 9 Oct 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36939879
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are Reference Values of the Thickness and the Thickening Fraction of the Diaphragm in Children Aged 0-8 Years?
- ClinicalTrials.gov ID
- NCT04589910
- Acronym / sponsor ID
- NL70476.078.19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra-sound arm | Other | Diagnostic Test: diaphragm thickness and thickening fractionUltrasound 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. |
Who may qualify
- Ages
- 0 months to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Neuromuscular diseases
- Lung diseases
- Recent abdominal or thoracic surgery (less than 3 month ago) - Deviations of the diaphragm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragm thickness and thickening fractionUltrasound 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. | Diagnostic test | Ultra-sound arm |
Primary outcome
diaphragm thickness
Time frame: Day 1
To determine diaphragm thickness and thickening fraction in healthy children below or equal to 8 years of age.
1 secondary outcome
Interrater reliability
Time frame: During 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 36939879Duyndam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diaphragm thickness and thickening fraction in people with Mechanical Ventilation Complication and Pediatric ALL, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragm thickness (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.