3D evaluation of diaphragm function using volume change measurements
3D Evaluation to Quantify Regional Volume Change Between FRC and TLC
Assistance Publique - Hôpitaux de Paris · NCT05339698
This study tests a new way to measure how well the diaphragm works by using 3D imaging to see changes in lung volume in people who may have breathing issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Garches) |
| Trial ID | NCT05339698 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a method for measuring inspiratory capacity (IC) through 3D analysis of thoraco-abdominal volume changes between functional residual capacity (FRC) and total lung capacity (TLC). Participants will undergo 3D visualization while maintaining a supine position and a five-second apnea to assess diaphragmatic function non-invasively. The study will also evaluate the inter-observer variability of IC measurements between trained technicians and pulmonologists. The goal is to enhance understanding of diaphragmatic dysfunction and improve diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who are suspected of having diaphragmatic dysfunction and can maintain five seconds of apnea in a supine position.
Not a fit: Patients who cannot lie in a supine position or maintain apnea for five seconds, as well as pregnant or breastfeeding individuals, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for accurately assessing diaphragmatic function in patients with suspected dysfunction.
How similar studies have performed: While this approach is innovative, similar studies utilizing 3D analysis for respiratory function have shown promise in enhancing diagnostic capabilities.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 18 - 90 years of age; * Patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position. Exclusion Criteria: * Decubitus impossible; * Apnea of 5 seconds impossible; * Pregnant or Breastfeeding; * Patient under juridic protection.
Where this trial is running
Garches
- Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP — Garches, France (RECRUITING)
Study contacts
- Principal investigator: Caroline HELIE — Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP
- Study coordinator: Frédéric LOFASO, MD, PhD
- Email: f.lofaso@aphp.fr
- Phone: + 33 (0)1 47 10 79 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diaphragmatic Dysfunction, Neuromuscular, Diaphragm, Non invasive, 3D analysis