Chronic Obstructive Pulmonary DiseaseNAVASYNCNCT01042080
Neurally Adjusted Ventilatory Assist and Synchrony in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing NAVA and Expiratory trigger (ET) in people with Chronic Obstructive Pulmonary Disease, run by Hôpital Européen Marseille at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NAVA and Expiratory trigger (ET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2009to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of chronic obstructive pulmonary disease
- Admitted for acute respiratory failure requiring invasive mechanical ventilation
- Currently receiving pressure support ventilation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Paul Desbief
Marseille, 13002
Fondation Hôpital Ambroise Paré
Marseille, 13006
About this study
Official title: Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease
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 %).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NAVA, Expiratory trigger (ET)
- Keywords
- Mechanical ventilation, Neurally adjusted ventilatory assist (NAVA), Acute respiratory failure, Chronic obstructive pulmonary disease, Weaning, Invasive mechanical ventilation, Positive Pressure support Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
Also called Neurally Adjusted Ventilatory Assist
Assisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes
Expiratory trigger (ET)Other
Varying the cycling criterion according to the percentage of peak inspiratory flow
| Study group | Role | What they receive |
|---|---|---|
| PSV-ET 25 | Active comparator | Pressure support ventilation with expiratory trigger set at 25 %. Receives: Other: Expiratory trigger (ET) |
| PSV-ET 50 | Active comparator | Pressure support ventilation with expiratory cycling set at 50 %. Receives: Other: Expiratory trigger (ET) |
| NAVA | Experimental | NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV. Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)
Measured: 5 minutes
Secondary outcomes (4)
Ineffective inspiratory effort
Measured: 5 minutes
Dynamic intrinsic PEEP
Measured: 5 minutes
Arterial blood gases
Measured: 20 minutes
Trigger delay
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerome Allardet-Servent, MD, Hôpital Européen Marseille
- Investigators
- Jérôme ALLARDET-SERVENT, MD, MSc, Principal investigator, Fondation Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042080
- Sponsor's protocol ID
- 2009-A01099-48
- Acronym
- NAVASYNC
- Status last verified
- Sep 2019
- First submitted
- 4 Jan 2010
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01042080
- Acronym / sponsor ID
- NAVASYNC / 2009-A01099-48
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Mechanical ventilation, Neurally adjusted ventilatory assist (NAVA), Acute respiratory failure, Chronic obstructive pulmonary disease, Weaning, Invasive mechanical ventilation, Positive Pressure support Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 %).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PSV-ET 25 | Active comparator | Other: Expiratory trigger (ET)Pressure support ventilation with expiratory trigger set at 25 %. |
| PSV-ET 50 | Active comparator | Other: Expiratory trigger (ET)Pressure support ventilation with expiratory cycling set at 50 %. |
| NAVA | Experimental | Device: NAVANAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of chronic obstructive pulmonary disease
- Admitted for acute respiratory failure requiring invasive mechanical ventilation
- Currently receiving pressure support ventilation
Key exclusion criteria (6 listed)
- Age < 18 years
- Respiratory rate > 35 bpm
- Severe hypoxemia with SpO2 < 88 % and FIO2 > 50 %
- Heart rate > 120 bpm
- Systolic arterial pressure < 90 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVAAlso: Neurally Adjusted Ventilatory AssistAssisted mechanical ventilation according to the electrical activity of the diaphragm recorded with a 16-FR naso-gastric tube mounted with EMG electrodes | Device | NAVA |
| Expiratory trigger (ET)Varying the cycling criterion according to the percentage of peak inspiratory flow | Other | PSV-ET 25, PSV-ET 50 |
Primary outcome
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)
Time frame: 5 minutes
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme ALLARDET-SERVENT, MD, MSc principal investigator
Fondation Hôpital Ambroise Paré
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA and Expiratory trigger (ET) in people with Chronic Obstructive Pulmonary Disease, run by Hôpital Européen Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.