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: May 18, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ineffective inspiratory effort [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
  • Dynamic intrinsic PEEP [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Arterial blood gases [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • Trigger delay [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: February 2015
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042080

Locations
France
Fondation Hôpital Ambroise Paré
Marseille, France, 13006
Hopital Paul Desbief
Marseille, France, 13002
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc Fondation Hôpital Ambroise Paré
  More Information

No publications provided

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: May 18, 2014
Health Authority: FRANCE: Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

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 September 30, 2014