Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography
ADULT
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
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
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2017
CompletedApril 14, 2017
April 1, 2017
4 months
April 10, 2017
April 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Healthy volunteers
EXPERIMENTALInterventions
The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator
Eligibility Criteria
You may qualify if:
- Healthy volunteer (male or female)
- Free and Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Henri Mondor
Créteil, 94440, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 14, 2017
Study Start
April 14, 2017
Primary Completion
July 30, 2017
Study Completion
July 30, 2017
Last Updated
April 14, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share