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Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction

This study has been completed.
Sponsor:
Collaborators:
University Hospital St Luc, Brussels
University Hospital Sart Tilman, Liege
University of Lausanne Hospitals
Notre Dame de Grace Hospital, Gosselies
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01074866
First received: February 23, 2010
Last updated: September 20, 2012
Last verified: January 2010
History of Changes
  Purpose

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.


Condition Intervention
Non Invasive Ventilation
Patient Ventilator Interaction
 Device: Neurally Adjusted Ventilatory Assist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effects of Neurally Adjusted Ventilatory Assist (NAVA) on Improving Patient-ventilator Interaction in Patients Undergoing Ventilation for Acute Respiratory Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Patient-ventilator synchronization parameters [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pressure support
Non invasive ventilation under pressure support (PS)
Active Comparator: Neurally Adjusted Ventilatory Assist
Non invasive ventilation under Neurally Adjusted ventilatory Assist
 Device: Neurally Adjusted Ventilatory Assist
Non invasive ventilation under Neurally adjusted Ventilatory Assist
Other Name: NAVA

Detailed Description:

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin

Exclusion Criteria:

  • severe hypoxemia requiring an FIO2>0.6
  • hemodynamic instability
  • known oesophageal problem
  • active upper gastro-intestinal bleeding
  • any other contraindication to the insertion of a naso-gastric tube
  • impaired consciousness or absence of patient cooperation
  • facial or laryngeal lesions contraindicating the use of NIV
  • poor short term prognosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074866

Locations
Belgium
St Luc University hospital
Brussels, Belgium
Bernard Lambermont
Liege, Belgium
Switzerland
HUG, University Hospital
Geneva, Switzerland, 1211
CHUV University hospital of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University Hospital, Geneva
University Hospital St Luc, Brussels
University Hospital Sart Tilman, Liege
University of Lausanne Hospitals
Notre Dame de Grace Hospital, Gosselies
Investigators
Study Director: Didier Tassaux, MD HUG, University hospital Geneva
  More Information

No publications provided

Responsible Party: Intensive Care Unit, HUG, University hospital of Geneva
ClinicalTrials.gov Identifier: NCT01074866     History of Changes
Other Study ID Numbers: NAVA_NIV
Study First Received: February 23, 2010
Last Updated: September 20, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Mechanical ventilation
Non invasive Ventilation
Patient-ventilator interaction
Pressure support
Neurally adjusted ventilatory assist

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013