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Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NAVASYNC)

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ClinicalTrials.gov Identifier: NCT01042080
Recruitment Status : Active, not recruiting
First Posted : January 5, 2010
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: NAVA Other: Expiratory trigger (ET) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : December 2009
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: PSV-ET 25
Pressure support ventilation with expiratory trigger set at 25 %.
 Other: Expiratory trigger (ET)
Varying the cycling criterion according to the percentage of peak inspiratory flow
Active Comparator: PSV-ET 50
Pressure support ventilation with expiratory cycling set at 50 %.
 Other: Expiratory trigger (ET)
Varying the cycling criterion according to the percentage of peak inspiratory flow
Experimental: NAVA
NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.
 Device: NAVA
Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes
Other Name: Neurally Adjusted Ventilatory Assist


Outcome Measures
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Primary Outcome Measures :
  1. Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi) [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. Ineffective inspiratory effort [ Time Frame: 5 minutes ]
  2. Dynamic intrinsic PEEP [ Time Frame: 5 minutes ]
  3. Arterial blood gases [ Time Frame: 20 minutes ]
  4. Trigger delay [ Time Frame: 5 minutes ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Inclusion Criteria:

  • History of chronic obstructive pulmonary disease
  • Admitted for acute respiratory failure requiring invasive mechanical ventilation
  • Currently receiving pressure support ventilation

Exclusion Criteria:

  • Age < 18 years
  • Respiratory rate > 35 bpm
  • Severe hypoxemia with SpO2 < 88 % and FIO2 > 50 %
  • Heart rate > 120 bpm
  • Systolic arterial pressure < 90 mmHg
  • Contraindication to naso-gastric tube's insertion
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01042080


Locations
France
Hopital Paul Desbief
Marseille, France, 13002
Fondation Hôpital Ambroise Paré
Marseille, France, 13006
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc Fondation Hôpital Ambroise Paré
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT01042080     History of Changes
Other Study ID Numbers: 2009-A01099-48
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Keywords provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:
Mechanical ventilation
Neurally adjusted ventilatory assist (NAVA)
Acute respiratory failure
Chronic obstructive pulmonary disease
 Weaning
Invasive mechanical ventilation
Positive Pressure support Ventilation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases