Diaphragmatic DysfunctionMATH3DNCT05339698
3D Evaluation to Quantify Regional Volume Change Between FRC and TLC
An observational study of Diaphragmatic Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diaphragmatic Dysfunction
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2022to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients addressed to the respiratory function laboratory for suspicion of diaphragmatic dysfunction
Who may be able to join
- Patients 18 - 90 years of age;
- Patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position.
Who cannot join
- Decubitus impossible;
- Apnea of 5 seconds impossible;
- Pregnant or Breastfeeding;
- Patient under juridic protection.
Trial locations and contacts
1 site in 1 country.
France1 site
Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP
Garches, 92380
About this study
The aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist.
Read the detailed description
3D visualization of the chest and abdomen surface in static condition is a simple and inexpensive solution to measure regional volume changes between two static respiratory volume positions. Five seconds of apnea is necessary for visualizing the thoraco-abdominal surface. If the two positions visualized correspond to the functional residual capacity (FRC) and the total lung capacity (TLC) the volume difference is inspiratory capacity (IC) which depends to the inspiratory muscles activation. This IC can be split in different thoraco-abdominal compartments and in supine position the abdominal contribution of this IC volume appreciates non-invasively diaphragmatic function. In addition asymmetry between right and left sides can appreciate unilateral diaphragmatic.
The aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist.
Accordingly, patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position will be proposed, by using the informed consent process, to participate to this study which consisted to beneficiate to a 3D trunk visualization at FRC and TLC during a spirometric IC measurement in supine position. Thoraco-abdominal volume difference between the two positions (FRC and TLC) will be calculated to obtain a 3D-IC volume. Then a Bland-Altman comparison will be done between the 3D-IC volumes measured and calculated by the two different observers (technician and pulmonologist), and the spirometric-IC volume considered as the reference. The Bland-Altman average discrepancies (the bias) and to the wide of the limits of agreement obtained will allow to select the best observer between the technician and the pulmonologist.
After the validation of the 3D-IC measurement against spirometry (difference > 10%), and after having confirmed that this analysis can be performed in routine by a pulmonary function technician, the next step will be to validate that the decrease of abdominal contribution of 3D-IC is an non-invasive index of diaphragmatic dysfunction. Accordingly, a linear regression analysis will be used in this study between the abdominal contribution to 3D-IC and the other parameters issued from exams prescribed by the clinician to confirm and evaluate diaphragmatic dysfunction. These other parameters are usually the fall of CV in supine position and/or a decrease of transdiaphragmatic pressure (Pdi) measurement by estimating the difference between oesophageal pressure (Peso) (intrathoracic pressure) and gastric pressure (Pga) (intra-abdominal pressure), [Pdi=Pga-Peso]. Pdi can be obtained during maximal voluntary efforts (the most frequent being the sniff test (Sniff Pdi)) or by using non-volitional test such as magnetic stimulation of the phrenic nerves (Twitch Pdi).
- Conditions
- Diaphragmatic Dysfunction
- Keywords
- Neuromuscular, Diaphragm, Non invasive, 3D analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory capacity using a 3D technique
Thoraco-abdominal volume difference between the two respiratory positions will be calculated to obtain a difference in respiratory volume between these two positions.
Measured: at baseline
Secondary outcomes (1)
Abdominal contribution to inspiratory capacity
Abdominal contribution to trunck volume change
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start2 Sep 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic DysfunctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric LOFASO, MD, PhD, Study director, Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHPCaroline HELIE, Principal investigator, Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339698
- Sponsor's protocol ID
- APHP220330
- Other IDs
- 2021-A02798-33
- Acronym
- MATH3D
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Evaluation to Quantify Regional Volume Change Between FRC and TLC
- ClinicalTrials.gov ID
- NCT05339698
- Acronym / sponsor ID
- MATH3D / APHP220330
- Conditions
- Diaphragmatic Dysfunction
- Keywords
- Neuromuscular, Diaphragm, Non invasive, 3D analysis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Apr 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 aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist.
Detailed description
3D visualization of the chest and abdomen surface in static condition is a simple and inexpensive solution to measure regional volume changes between two static respiratory volume positions. Five seconds of apnea is necessary for visualizing the thoraco-abdominal surface. If the two positions visualized correspond to the functional residual capacity (FRC) and the total lung capacity (TLC) the volume difference is inspiratory capacity (IC) which depends to the inspiratory muscles activation. This IC can be split in different thoraco-abdominal compartments and in supine position the abdominal contribution of this IC volume appreciates non-invasively diaphragmatic function. In addition asymmetry between right and left sides can appreciate unilateral diaphragmatic.
The aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist.
Accordingly, patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position will be proposed, by using the informed consent process, to participate to this study which consisted to beneficiate to a 3D trunk visualization at FRC and TLC during a spirometric IC measurement in supine position. Thoraco-abdominal volume difference between the two positions (FRC and TLC) will be calculated to obtain a 3D-IC volume. Then a Bland-Altman comparison will be done between the 3D-IC volumes measured and calculated by the two different observers (technician and pulmonologist), and the spirometric-IC volume considered as the reference. The Bland-Altman average discrepancies (the bias) and to the wide of the limits of agreement obtained will allow to select the best observer between the technician and the pulmonologist.
After the validation of the 3D-IC measurement against spirometry (difference > 10%), and after having confirmed that this analysis can be performed in routine by a pulmonary function technician, the next step will be to validate that the decrease of abdominal contribution of 3D-IC is an non-invasive index of diaphragmatic dysfunction. Accordingly, a linear regression analysis will be used in this study between the abdominal contribution to 3D-IC and the other parameters issued from exams prescribed by the clinician to confirm and evaluate diaphragmatic dysfunction. These other parameters are usually the fall of CV in supine position and/or a decrease of transdiaphragmatic pressure (Pdi) measurement by estimating the difference between oesophageal pressure (Peso) (intrathoracic pressure) and gastric pressure (Pga) (intra-abdominal pressure), [Pdi=Pga-Peso]. Pdi can be obtained during maximal voluntary efforts (the most frequent being the sniff test (Sniff Pdi)) or by using non-volitional test such as magnetic stimulation of the phrenic nerves (Twitch Pdi).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients addressed to the respiratory function laboratory for suspicion of diaphragmatic dysfunction
Key inclusion criteria (2 listed)
- Patients 18 - 90 years of age;
- Patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position.
Key exclusion criteria (4 listed)
- Decubitus impossible;
- Apnea of 5 seconds impossible;
- Pregnant or Breastfeeding;
- Patient under juridic protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inspiratory capacity using a 3D technique
Time frame: at baseline
Thoraco-abdominal volume difference between the two respiratory positions will be calculated to obtain a difference in respiratory volume between these two positions.
1 secondary outcome
Abdominal contribution to inspiratory capacity
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Diaphragmatic Dysfunction
Not yet recruitingObservational study
Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock
Respiration Failure, Diaphragmatic Dysfunction
Enrolling by invitation
Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy
Not yet recruitingObservational study
Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients
Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Not yet recruiting
Interscalene Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopic Surgeries
Recruiting
Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery
Diaphragmatic Dysfunction
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.
Frédéric LOFASO, MD, PhD study director
Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP
Caroline HELIE principal investigator
Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP
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 Dysfunction, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Inspiratory capacity using a 3D technique (time frame: at baseline). 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 19 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.