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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02056093 |
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Date of registration:
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18/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
PAVANAVA |
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Scientific title:
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Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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16 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02056093 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Matthieu SCHMIDT, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Association pour le Développement et l'Organisation de la Recherche en Pneumologie |
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Name:
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Matthieu SCHMIDT, MD |
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Address:
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Telephone:
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Email:
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matthieuschmidt@yahoo.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Intubated patients.
- Mechanical ventilation for a respiratory reason.
- Expected duration of Mechanical ventilation > 48 hrs.
- Spontaneous breathing.
- Sedations stopped for more than 24 hours.
Exclusion Criteria:
- - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12
months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days,
history of esophageal varices, facial trauma or surgery, neuromuscular diseases,
individuals with known or suspected phrenic nerve dysfunction.
- Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular
diseases.
- Hemodynamic instability defined as the current administration of vasopressors or
inotropic drugs.
- Severe hypoxemia defined as PaO2/FiO2 ratio <200.
- Decision to withhold life-sustaining treatment.
- Pregnant women.
- Minors < 18 years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Respiratory Failure
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Intervention(s)
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Device: PAV mode
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Device: PSV mode
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Device: NAVA
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Primary Outcome(s)
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Breathing pattern variability
[Time Frame: February 2014]
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Secondary Outcome(s)
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Patient-ventilator asynchrony
[Time Frame: February, 2014]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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