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NCT Number: NCT05339698

3D Evaluation to Quantify Regional Volume Change Between FRC and TLC

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP

Garches, 92380, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Abdominal contribution to inspiratory capacity

    Time frame: at baseline

    Abdominal contribution to trunck volume change

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MATH3D

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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