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

History of Changes

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:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Further study details as provided by Jerome Allardet-Servent, MD, 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

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
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 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

ClinicalTrials.gov processed this record on June 23, 2017

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