NCT03313141

Brief Summary

The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 4, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

18 days

First QC Date

October 4, 2017

Last Update Submit

December 15, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Transdiaphragmatic pressure

    The transdiaphragmatic pressure is the sum of absolute values of gastric and oesophagal pressures

    2 hours

Study Arms (1)

Subjects

EXPERIMENTAL

Only one arm is considered

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Volitional and non volitional respiratory tasks

Also known as: Magnetic and electrical phrenic nerve stimulation
Subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteer

You may not qualify if:

  • chronic respiratory, neurologic or cardiac disease
  • swallowing disorders
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitie Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: To compare diaphragm elastrography provided by ultrasound to diaphragm function indices provided by magnetic/electrical phrenic nerves stimulation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 18, 2017

Study Start

October 9, 2017

Primary Completion

October 27, 2017

Study Completion

October 27, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

FR(1)