Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric PatientsNCT05382247
Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric Patients
A study testing ultrasonography in people with Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric Patients, run by Sohag University at 1 site in Egypt.
Trial summary
The diaphragm is the main muscle of respiration during resting breathing (1), and is formed by two muscles with dual innervation, joined by a central tendon. When it is contracted, the caudal movement increases the volume of the rib cage, generating the negative pressure necessary for inspiratory flow (2). Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric Patients
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2022to 13 May 2023
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 6 months - 14 years, diagnosed with neuromuscular diseases, attending the Pediatric neurology clinic at Sohag University Hospital.
Who cannot join
- History of abdominal or thoracic surgery that may influence diaphragm motion.
- Prolonged mechanical ventilation as it may affect diaphragm thickness and motion.
- Presence of supra or subdiaphragmatic lesion limiting diaphragm motion
Trial locations and contacts
1 site in 1 country.
mostafa m AboSedera, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ELsheref, professor
About this study
The diaphragm is the main muscle of respiration during resting breathing (1), and is formed by two muscles with dual innervation, joined by a central tendon. When it is contracted, the caudal movement increases the volume of the rib cage, generating the negative pressure necessary for inspiratory flow (2). When respiratory demands are increased or diaphragm function is impaired, rib cage muscles and expiratory muscles are progressively recruited. In some patients with diaphragm dysfunction, this compensation is associated with minimal or no respiratory symptoms. In other patients, this compensation is associated with significant respiratory symptoms. Early diagnosis of diaphragmatic dysfunction is essential, because it may be responsive to therapeutic intervention (3). The ultimate causes of diaphragmatic dysfunction can be broadly grouped into three major categories: disorders of central nervous system or peripheral neurons, disorders of the neuromuscular junction and disorders of the contractile machinery of the diaphragm itself (4). So In summary, motion and contractile force of the diaphragm may be affected by pathological alterations of the following anatomical structures:
- - Central nervous system
- - Phrenic nerve
- - Neuromuscular junction
- - Diaphragm muscle
- - Thoracic cage
- - Upper abdomen In patients on mechanical ventilation, the positive end expiratory pressure (PEEP) level also decrease diaphragmatic motion by increasing the end expiratory lung volume and thereby lowering the diaphragmatic dome at the end of expiration (3).
Diaphragm muscle dysfunction is increasingly recognized as an important element of several diseases including neuromuscular diseases leading to a restrictive respiratory pattern (1). The assessment of respiratory muscle function is of paramount interest in patients with neuromuscular disorders. In patients with neuromuscular diseases, respiratory symptoms are subtle and usually appear late in the clinical course of the disease, partly because of the limited mobility of patients due to peripheral muscle weakness, except in the case of acute respiratory failure due to infection. Clinical presentation is quite variable in cases of diaphragmatic failure. Orthopnea may be present and paradoxical abdominal motion may be observed during inspiration, with the abdomen moving inward while the rib cage expands (3). Different structural and functional techniques are available for evaluating the diaphragm. Each technique has its strengths and weaknesses (5). Imaging of respiratory muscles was divided into static and dynamic techniques. Static techniques comprise chest radiography, B-mode (brightness mode) ultrasound, CT and MRI, and are used to assess the position and thickness of the diaphragm and the other respiratory muscles. Dynamic techniques include fluoroscopy, M-mode (motion mode) ultrasound and MRI, used to assess diaphragm motion in one or more directions (6). The recent development of diaphragmatic ultrasound has revolutionized diaphragm evaluation (2). Diaphragm ultrasonography was first described in the late 1960s as a means to determine position and size of supra- and subphrenic mass lesions, and to assess the motion and contour of the diaphragm (1). Two decades later, Wait et al, developed a technique to measure diaphragm thickness based on ultrasonography. Later on the investigators reported a close correlation between diaphragm thickness measured in cadavers using ultrasound imaging and thickness measured with a ruler (7). it has been shown to be similar in accuracy to most other imaging modalities for diaphragm assessment (5), as it can be used to assess bilateral diaphragmatic morphology and function in real time, permitting follow-up without exposure to radiation. It is, moreover, affordable and ubiquitous. (2). First developed in intensive care, mainly for weaning from mechanical ventilation, its use is now extending to pulmonology. Different measurements are described such as diaphragmatic excursion, diaphragmatic thickness and diaphragmatic thickening fraction (8). US measurements of diaphragm muscle thickness and thickening with inspiration have been shown to be superior to phrenic nerve conduction studies (NCS), chest radiographs, and fluoroscopy for detection of neuromuscular disease affecting the diaphragm. The main use in pulmonology is for the respiratory evaluation of patients with neuromuscular diseases, for the search of isolated diaphragmatic impairment and for patients with chronic obstructive lung diseases. Numerous studies are in progress to better determine the role of diaphragmatic ultrasound (5).
- Being tested
- ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
Full history taking, thorough clinical examination, review of participants medical files.
Patients will be typically examined during spontaneous respiration to help assessement of diaphragmatic motion.
The supine position will be used whenever possible to avoid overall variability, side-to-side variability, and for greater reproducibility.
Patients can be examined in quiet respiration and during deep breathing or sniff maneuver.
For uncooperative patients appropriate sedative for age will be used. Assessement of diaphragmatic function: the analysis of the dome excursion with M mode approach Evaluation of diaphragmatic thickness and thickening during inspiration by analyzing the apposition zone.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients with neuromuscular diseases | Active comparator | Not described Receives: Device: ultrasonography |
| children not suffering from neuromuscular diseases | Active comparator | Not described Receives: Device: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragmatic excursion
To assess the diaphragmatic motion by M-mode
Measured: 1 year
Secondary outcomes (1)
diaphragmatic thickness
diaphragmatic thickness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start13 May 2022
- Primary completion13 May 2023 (estimated)
- Study completion13 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Kamel Morssi, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382247
- Sponsor's protocol ID
- Soh-Med-22-5-08
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Laghi FA Jr, Saad M, Shaikh H. Ultrasound and non-ultrasound imaging techniques in the assessment of diaphragmatic dysfunction. BMC Pulm Med. 2021 Mar 15;21(1):85. doi: 10.1186/s12890-021-01441-6.
PubMed 33722215Sayas Catalan J, Hernandez-Voth A, Villena Garrido MV. Diaphragmatic Ultrasound: An Innovative Tool Has Become Routine. Arch Bronconeumol (Engl Ed). 2020 Apr;56(4):201-203. doi: 10.1016/j.arbres.2019.06.020. Epub 2019 Aug 3. No abstract available. English, Spanish.
PubMed 31383496Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
PubMed 33237154Boussuges A, Rives S, Finance J, Bregeon F. Assessment of diaphragmatic function by ultrasonography: Current approach and perspectives. World J Clin Cases. 2020 Jun 26;8(12):2408-2424. doi: 10.12998/wjcc.v8.i12.2408.
PubMed 32607319
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric Patients
- ClinicalTrials.gov ID
- NCT05382247
- Acronym / sponsor ID
- Soh-Med-22-5-08
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 May 2023 (estimated)
- Study completion
- 13 May 2023 (estimated)
- First posted
- 19 May 2022 (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.
The diaphragm is the main muscle of respiration during resting breathing (1), and is formed by two muscles with dual innervation, joined by a central tendon. When it is contracted, the caudal movement increases the volume of the rib cage, generating the negative pressure necessary for inspiratory flow (2). When respiratory demands are increased or diaphragm function is impaired, rib cage muscles and expiratory muscles are progressively recruited. In some patients with diaphragm dysfunction, this compensation is associated with minimal or no respiratory symptoms. In other patients, this compensation is associated with significant respiratory symptoms. Early diagnosis of diaphragmatic dysfunction is essential, because it may be responsive to therapeutic intervention (3). The ultimate causes of diaphragmatic dysfunction can be broadly grouped into three major categories: disorders of central nervous system or peripheral neurons, disorders of the neuromuscular junction and disorders of the contractile machinery of the diaphragm itself (4). So In summary, motion and contractile force of the diaphragm may be affected by pathological alterations of the following anatomical structures:
- - Central nervous system
- - Phrenic nerve
- - Neuromuscular junction
- - Diaphragm muscle
- - Thoracic cage
- - Upper abdomen In patients on mechanical ventilation, the positive end expiratory pressure (PEEP) level also decrease diaphragmatic motion by increasing the end expiratory lung volume and thereby lowering the diaphragmatic dome at the end of expiration (3).
Diaphragm muscle dysfunction is increasingly recognized as an important element of several diseases including neuromuscular diseases leading to a restrictive respiratory pattern (1). The assessment of respiratory muscle function is of paramount interest in patients with neuromuscular disorders. In patients with neuromuscular diseases, respiratory symptoms are subtle and usually appear late in the clinical course of the disease, partly because of the limited mobility of patients due to peripheral muscle weakness, except in the case of acute respiratory failure due to infection. Clinical presentation is quite variable in cases of diaphragmatic failure. Orthopnea may be present and paradoxical abdominal motion may be observed during inspiration, with the abdomen moving inward while the rib cage expands (3). Different structural and functional techniques are available for evaluating the diaphragm. Each technique has its strengths and weaknesses (5). Imaging of respiratory muscles was divided into static and dynamic techniques. Static techniques comprise chest radiography, B-mode (brightness mode) ultrasound, CT and MRI, and are used to assess the position and thickness of the diaphragm and the other respiratory muscles. Dynamic techniques include fluoroscopy, M-mode (motion mode) ultrasound and MRI, used to assess diaphragm motion in one or more directions (6). The recent development of diaphragmatic ultrasound has revolutionized diaphragm evaluation (2). Diaphragm ultrasonography was first described in the late 1960s as a means to determine position and size of supra- and subphrenic mass lesions, and to assess the motion and contour of the diaphragm (1). Two decades later, Wait et al, developed a technique to measure diaphragm thickness based on ultrasonography. Later on the investigators reported a close correlation between diaphragm thickness measured in cadavers using ultrasound imaging and thickness measured with a ruler (7). it has been shown to be similar in accuracy to most other imaging modalities for diaphragm assessment (5), as it can be used to assess bilateral diaphragmatic morphology and function in real time, permitting follow-up without exposure to radiation. It is, moreover, affordable and ubiquitous. (2). First developed in intensive care, mainly for weaning from mechanical ventilation, its use is now extending to pulmonology. Different measurements are described such as diaphragmatic excursion, diaphragmatic thickness and diaphragmatic thickening fraction (8). US measurements of diaphragm muscle thickness and thickening with inspiration have been shown to be superior to phrenic nerve conduction studies (NCS), chest radiographs, and fluoroscopy for detection of neuromuscular disease affecting the diaphragm. The main use in pulmonology is for the respiratory evaluation of patients with neuromuscular diseases, for the search of isolated diaphragmatic impairment and for patients with chronic obstructive lung diseases. Numerous studies are in progress to better determine the role of diaphragmatic ultrasound (5).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with neuromuscular diseases | Active comparator | Device: ultrasonography |
| children not suffering from neuromuscular diseases | Active comparator | Device: ultrasonography |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children and adolescents aged 6 months - 14 years, diagnosed with neuromuscular diseases, attending the Pediatric neurology clinic at Sohag University Hospital.
Key exclusion criteria (3 listed)
- History of abdominal or thoracic surgery that may influence diaphragm motion.
- Prolonged mechanical ventilation as it may affect diaphragm thickness and motion.
- Presence of supra or subdiaphragmatic lesion limiting diaphragm motion
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 |
|---|---|---|
| ultrasonographyFull history taking, thorough clinical examination, review of participants medical files. Patients will be typically examined during spontaneous respiration to help assessement of diaphragmatic motion. The supine position will be used whenever possible to avoid overall variability, side-to-side variability, and for greater reproducibility. Patients can be examined in quiet respiration and during deep breathing or sniff maneuver. For uncooperative patients appropriate sedative for age will be used. Assessement of diaphragmatic function: the analysis of the dome excursion with M mode approach Evaluation of diaphragmatic thickness and thickening during inspiration by analyzing the apposition zone. | Device | children not suffering from neuromuscular diseases, pediatric patients with neuromuscular diseases |
Primary outcome
diaphragmatic excursion
Time frame: 1 year
To assess the diaphragmatic motion by M-mode
1 secondary outcome
diaphragmatic thickness
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 33722215Laghi FA Jr, Saad M, Shaikh H. Ultrasound and non-ultrasound imaging techniques in the assessment of diaphragmatic dysfunction. BMC Pulm Med. 2021 Mar 15;21(1):85. doi: 10.1186/s12890-021-01441-6.
- Background: PubMed 31383496Sayas Catalan J, Hernandez-Voth A, Villena Garrido MV. Diaphragmatic Ultrasound: An Innovative Tool Has Become Routine. Arch Bronconeumol (Engl Ed). 2020 Apr;56(4):201-203. doi: 10.1016/j.arbres.2019.06.020. Epub 2019 Aug 3. No abstract available. English, Spanish.
- Background: PubMed 33237154Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
- Background: PubMed 32607319Boussuges A, Rives S, Finance J, Bregeon F. Assessment of diaphragmatic function by ultrasonography: Current approach and perspectives. World J Clin Cases. 2020 Jun 26;8(12):2408-2424. doi: 10.12998/wjcc.v8.i12.2408.
- Individual participant dataSharing planned: Yes
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.
mostafa m AboSedera, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography in people with Ultrasonographic Assessement Of Diaphragm In Neuromuscular Diseases In Pediatric Patients, run by Sohag University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 19 May 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lamiaa k morssi, resident doctor (01028979861, LamiaaKamel@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragmatic excursion (time frame: 1 year). 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 NCT05382247, which also lists 4 linked publications.
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 19 May 2022.