Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Not Applicable

• Conditions: Ultrasonography; Diaphragm
• Interventions: Other: Creation and detection of patient-respirator asynchronies

• Registration Number: NCT03114384
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-11
• Last Update Submitted: 2017-04-11
• Study Start: 2017-04-14
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Creation and detection of patient-respirator asynchronies	-

Primary Outcome Measures

Name	Time	Method
Asynchronies detection with diaphragm ultrasonography	thirty minutes	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.

Trial Locations

Locations (1)

Groupe Hospitalier Henri Mondor; 🇫🇷 Creteil, France