Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NAVASYNC)
This study is ongoing, but not recruiting participants.
Sponsor:
Hôpital Européen Marseille
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT01042080
First received: January 4, 2010
Last updated: February 21, 2016
Last verified: February 2016
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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: | November 2016 |
| 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) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042080
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: | February 21, 2016 |
| 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 29, 2016