Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography (ADULT)

Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.

These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.

Study Overview

• Status: Unknown
• Conditions: Ultrasonography; Diaphragm
• Intervention / Treatment: Other: Creation and detection of patient-respirator asynchronies

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94440
    • Recruiting
    • Groupe Hospitalier Henri Mondor
    • Contact: Armand Mekontso Dessap, Pr; Phone Number: + 33 1 49 81 23 94; Email: armand.dessap@aphp.fr
    • Principal Investigator: CARTEAUX Guillaume, Dr
    • Sub-Investigator: VIVIER Emmanuel, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteer (male or female)
• Free and Informed Consent

Exclusion Criteria:

• Known pregnancy, parturient or nursing mother
• Minor under 18 years of age
• Major incapable
• Non-affiliation to the social security scheme
• Any history of respiratory pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers	Other: Creation and detection of patient-respirator asynchronies; The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchronies detection with diaphragm ultrasonography	Evaluation of the agreement between asynchronous subject-ventilator detection using diaphragm ultrasonography and detecting the same events in using the electromyogram of the respiratory muscles (as a reference technique.	thirty minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): April 14, 2017
• Primary Completion (Anticipated): July 30, 2017
• Study Completion (Anticipated): July 30, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017-A00346-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No