NCT05339698

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Sep 2022Sep 2026

First Submitted

Initial submission to the registry

April 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 2, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

April 15, 2022

Last Update Submit

November 18, 2025

Conditions

Diaphragmatic Dysfunction

Keywords

NeuromuscularDiaphragmNon invasive3D analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    at baseline

Secondary Outcomes (1)

  • Abdominal contribution to inspiratory capacity

    at baseline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients addressed to the respiratory function laboratory for suspicion of diaphragmatic dysfunction

You may qualify if:

  • Patients 18 - 90 years of age;
  • Patients addressed for suspicion of diaphragmatic dysfunction, and able to maintain 5 sec of apnea in supine position.

You may not qualify if:

  • Decubitus impossible;
  • Apnea of 5 seconds impossible;
  • Pregnant or Breastfeeding;
  • Patient under juridic protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Garches, 92380, France

Location

Study Officials

  • Frédéric LOFASO, MD, PhD

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

    STUDY DIRECTOR

  • Caroline HELIE

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 21, 2022

Study Start

September 2, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)