Diaphragmatic ParalysisDYSDIANCT03463798
Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
An observational study of Diaphragmatic Paralysis and Healthy Volunteers, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragmatic Paralysis, Healthy Volunteers
- What is being tested?
- Sonar and Structured light plethysmography (SLP)
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2018to 21 Sep 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.
Who may be able to join
- no respiratory disease
- no neurologic disease
- no thoracic deformation
- patients with a suspicion of diaphragmatic dysfunction
Who cannot join
- respiratory disease
- neurologic disease
- thoracic deformation
- FOR PATIENTS
- pregnant women
- contraindications to standard procedure requiring transdiaphragmatic measurement
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
About this study
this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.
Read the detailed description
The measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using SLP and Sonar devices.
Subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. The SLP and the Sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. Data will be collected during 5 minutes of tidal breathing. The same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. During both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (IC) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.
- Conditions
- Diaphragmatic Paralysis, Healthy Volunteers
- Being tested
- Sonar, Structured light plethysmography (SLP)
- Keywords
- structured light plethysmography, sonar, transdiaphragmatic pressure
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonarDevice
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Structured light plethysmography (SLP)Device
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with a suspicion of diaphragmatic dysfunction Receives: Device: Sonar; Device: Structured light plethysmography (SLP) | |
| Healthy volunteers | Subjects without any medical condition Receives: Device: Sonar; Device: Structured light plethysmography (SLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude of displacement of thoraco-abdominal compartments
asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres
Measured: 10 minutes
Secondary outcomes (1)
displacement speed of thoraco-abdominal compartments
asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start11 Jun 2018
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic ParalysisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierantonio LAVENEZIANA, MD, PhD, Principal investigator, UMRS_1158
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463798
- Sponsor's protocol ID
- 2017-A03665-48
- Acronym
- DYSDIA
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2018
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
- ClinicalTrials.gov ID
- NCT03463798
- Acronym / sponsor ID
- DYSDIA / 2017-A03665-48
- Conditions
- Diaphragmatic Paralysis, Healthy Volunteers
- Keywords
- structured light plethysmography, sonar, transdiaphragmatic pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 13 Mar 2018 (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.
this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.
Detailed description
The measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using SLP and Sonar devices.
Subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. The SLP and the Sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. Data will be collected during 5 minutes of tidal breathing. The same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. During both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (IC) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Sonar, Device: Structured light plethysmography (SLP)Patients with a suspicion of diaphragmatic dysfunction |
| Healthy volunteers | – | Device: Sonar, Device: Structured light plethysmography (SLP)Subjects without any medical condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.
Key inclusion criteria (4 listed)
- no respiratory disease
- no neurologic disease
- no thoracic deformation
- patients with a suspicion of diaphragmatic dysfunction
Key exclusion criteria (6 listed)
- respiratory disease
- neurologic disease
- thoracic deformation
- FOR PATIENTS
- pregnant women
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 |
|---|---|---|
| SonarMeasurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly | Device | Healthy volunteers, Patients |
| Structured light plethysmography (SLP)Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly | Device | Healthy volunteers, Patients |
Primary outcome
amplitude of displacement of thoraco-abdominal compartments
Time frame: 10 minutes
asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres
1 secondary outcome
displacement speed of thoraco-abdominal compartments
Time frame: 10 minutes
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 14 Sep 2023.
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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.
Pierantonio LAVENEZIANA, MD, PhD principal investigator
UMRS_1158
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragmatic Paralysis and Healthy Volunteers, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
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 4 inclusion and 6 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 14 Sep 2023. 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 France. 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?
amplitude of displacement of thoraco-abdominal compartments (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.