Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Ultrasonography Clinical Trial

— ADULT  

Official title:

Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03114384
• Other study ID #: 2017-A00346-47
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2017
• Last updated: April 11, 2017
• Start date: April 14, 2017
• Est. completion date: July 30, 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: Guillaume Carteaux, Dr
• Phone: + 33 1 49 81 23 94
• Email: guillaume.carteaux[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diaphragm
• Ultrasonography

Intervention

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

Locations

Country	Name	City	State
France	Groupe Hospitalier Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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