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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT01042080
First received: January 4, 2010
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
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 Intervention
Chronic Obstructive Pulmonary Disease
Device: NAVA
Other: Expiratory trigger (ET)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Hôpital Européen Marseille:

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

Secondary Outcome Measures:
  • Ineffective inspiratory effort [ Time Frame: 5 minutes ]
  • Dynamic intrinsic PEEP [ Time Frame: 5 minutes ]
  • Arterial blood gases [ Time Frame: 20 minutes ]
  • Trigger delay [ Time Frame: 5 minutes ]

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: November 2018
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received: January 4, 2010
Last Updated: April 25, 2017

Keywords provided by 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

ClinicalTrials.gov processed this record on April 27, 2017