Main
|
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: |
|
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:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Laboratoire TIMC-IMAG - La Tronche - France |
|
Name:
|
Frédéric Lofaso, MD-PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hopital Raymond Poincare - Garches - France |
|
Name:
|
Nicolas Terzi, MD-PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
CHU de Caen - INSERM U1075 - France |
|
Name:
|
Henri Meric |
Address:
|
|
Telephone:
|
|
Email:
|
|
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|