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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Device: NAVA Other: Expiratory trigger (ET) | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: PSV-ET 25
Pressure support ventilation with expiratory trigger set at 25 %.
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Other: Expiratory trigger (ET)
Varying the cycling criterion according to the percentage of peak inspiratory flow
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Active Comparator: PSV-ET 50
Pressure support ventilation with expiratory cycling set at 50 %.
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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.
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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
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- Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi) [ Time Frame: 5 minutes ]
- 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 ]

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

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
France | |
Hopital Paul Desbief | |
Marseille, France, 13002 | |
Fondation Hôpital Ambroise Paré | |
Marseille, France, 13006 |
Principal Investigator: | Jérôme ALLARDET-SERVENT, MD, MSc | Fondation Hôpital Ambroise Paré |
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 |