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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01614873
Date of registration: 06/06/2012
Prospective Registration: No
Primary sponsor: Centre d'Investigation Clinique et Technologique 805
Public title: Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation
Scientific title: Comparison of Breathing Pattern During PSV and NAVA
Date of first enrolment: May 2012
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01614873
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Pascale Calabrese, PhD
Address: 
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Email:
Affiliation:  Laboratoire TIMC-IMAG - La Tronche - France
Name:     Frédéric Lofaso, MD-PhD
Address: 
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Affiliation:  Hopital Raymond Poincare - Garches - France
Name:     Nicolas Terzi, MD-PhD
Address: 
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Affiliation:  CHU de Caen - INSERM U1075 - France
Name:     Henri Meric
Address: 
Telephone:
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Affiliation:  EA 4497 - Hopital Raymond Poincare - Garches -France
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Healthy Subject without any chronic disease

Exclusion Criteria:

- Absence of consent

- Pregnant



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Respiratory System Abnormalities
Intervention(s)
Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden
Primary Outcome(s)
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [Time Frame: 2h]
Secondary Outcome(s)
Electrical diaphragmatic activity recorded by mechanical ventilator [Time Frame: 2h]
Tidal volume evaluated by optoelectronic plethysmography [Time Frame: 2h]
Secondary ID(s)
2012-A0030043
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Adep Assistance
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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