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Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist (PAVANAVA)

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ClinicalTrials.gov Identifier: NCT02056093
Recruitment Status : Unknown
Verified February 2014 by Matthieu SCHMIDT, Pierre and Marie Curie University.
Recruitment status was:  Recruiting
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Matthieu SCHMIDT, Pierre and Marie Curie University

Brief Summary:
In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: PSV mode Device: PAV mode Device: NAVA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Study Start Date : September 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Intubated patients
Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.
Device: PSV mode
Application of PSV in all patients

Device: PAV mode
Application of PAV mode in all patients

Device: NAVA



Primary Outcome Measures :
  1. Breathing pattern variability [ Time Frame: February 2014 ]
    The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)


Secondary Outcome Measures :
  1. Patient-ventilator asynchrony [ Time Frame: February, 2014 ]
    Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)


Other Outcome Measures:
  1. Electrical diaphragm activity Gas exchange [ Time Frame: February 2014 ]
    measured by the NAVA probe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056093


Locations
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France
Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere Recruiting
Paris, Ile de France, France, 75013
Contact: Matthieu SCHMIDT, MD       matthieuschmidt@yahoo.fr   
Principal Investigator: Matthieu Schmidt, MD         
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
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Principal Investigator: Matthieu SCHMIDT, MD Association pour le Développement et l'Organisation de la Recherche en Pneumologie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthieu SCHMIDT, Dr, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT02056093    
Other Study ID Numbers: ADOREP
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Keywords provided by Matthieu SCHMIDT, Pierre and Marie Curie University:
NAVA - PAV- Breathing Variability - Asynchrony
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases