Respiratory System AbnormalitiesNCT01614873
Comparison of Breathing Pattern During Neurally Adjusted Ventilatory Assist Ventilation and Pressure Support Ventilation
A study testing Servo-i® ventilator, MAQUET,Critical Care, Sweden in people with Respiratory System Abnormalities, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory System Abnormalities
- What is being tested?
- Servo-i® ventilator, MAQUET,Critical Care, Sweden
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Aug 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Healthy Subject without any chronic disease
Who cannot join
- Absence of consent
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Breathing Pattern During PSV and NAVA
Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)
Read the detailed description
Eligibility : healthy subject without respiratory complications in the past
Subjects will breath spontaneously without mechanical ventilation, with Pressure Support Ventilation and with Neurally Adjusted Ventilatory Assist during.
Three levels of pressurisation will be tested : 5 cmH2O, 8 cmH2O and 12 cmH2O Duration of each condition will be about 15 minutes.
Measurements will include:Flow, airway pressure, SaO2, PtCO2, diaphragmatic electromyography, chest wall motion by optoelectronic plethysmography
- Conditions
- Respiratory System Abnormalities
- Being tested
- Servo-i® ventilator, MAQUET,Critical Care, Sweden
- Keywords
- Breathing Pattern, Mechanical Ventilation, Pressure support ventilation, Neurally Adjusted Ventilatory Assist
- Medical subject headings
- Respiratory System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Servo-i® ventilator, MAQUET,Critical Care, SwedenDevice
Also called PSV
Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). Subject will be ventilated with a mouthpiece interface. NAVA will be compared to Pressure Support using the same ventilator. Once the pattern of breathing will be stabilized (10 minutes) in each condition (see arm) the following parameters will be recorded during 5 minutes and compared : tidal volume, inspiratory time, expiratory time, transcutaneous CO2 pressure, diaphragmatic Emg activity, delay between the inspiratory activity initiation and positive pressure initiation, delay between the end of the inspiratory effort and the end of pressurisation.
| Study group | Role | What they receive |
|---|---|---|
| Pressure Support Ventilator | Active comparator | Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden).
During pressure support the inspiratory muscles are assisted by a constant inspiratory pressure adjusted by the prescriptor and applied to the airway by either an invasive or a non invasive interface. Then the subject initiate the inspiratory effort and a constant pressure is delivered to the airway in order to assist inspiration. Three levels of pressure will be tested (5 cmH2O, 8 cmH2O and 12 cmH2O) Receives: Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden |
| NAVA | Experimental | Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram. Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). During NAVA the inspiratory muscles are assisted by a pressure which is proportional to this electrical activity. Then the subject initiate the inspiratory effort and a pressure proportional to the integrated EMG activity is delivered to the airway in order to assist inspiration. The adjustment of the level of NAVA (expressed in cmH2O/microvolt) will be adjusted in order to obtain a peak pressure similar to pressure support (5 cmH2O, 8 cmH2O and 12 cmH2O) Receives: Device: Servo-i® ventilator, MAQUET,Critical Care, Sweden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Measured: 2h
Secondary outcomes (2)
Tidal volume evaluated by optoelectronic plethysmography
Measured: 2h
Electrical diaphragmatic activity recorded by mechanical ventilator
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory System AbnormalitiesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Principal investigator, Lofaso, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Frédéric Lofaso, MD-PhD, Principal investigator, Hopital Raymond Poincare - Garches - FranceNicolas Terzi, MD-PhD, Principal investigator, CHU de Caen - INSERM U1075 - FrancePascale Calabrese, PhD, Study director, Laboratoire TIMC-IMAG - La Tronche - FranceHenri Meric, Principal investigator, EA 4497 - Hopital Raymond Poincare - Garches -France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614873
- Sponsor's protocol ID
- 2012-A0030043
- Status last verified
- Apr 2013
- First submitted
- 6 Jun 2012
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.
PubMed 24508509
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breathing Pattern During PSV and NAVA
- ClinicalTrials.gov ID
- NCT01614873
- Acronym / sponsor ID
- 2012-A0030043
- Conditions
- Respiratory System Abnormalities
- Keywords
- Breathing Pattern, Mechanical Ventilation, Pressure support ventilation, Neurally Adjusted Ventilatory Assist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Adep Assistance
- Study start
- May 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Jun 2012 (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.
Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)
Detailed description
Eligibility : healthy subject without respiratory complications in the past
Subjects will breath spontaneously without mechanical ventilation, with Pressure Support Ventilation and with Neurally Adjusted Ventilatory Assist during.
Three levels of pressurisation will be tested : 5 cmH2O, 8 cmH2O and 12 cmH2O Duration of each condition will be about 15 minutes.
Measurements will include:Flow, airway pressure, SaO2, PtCO2, diaphragmatic electromyography, chest wall motion by optoelectronic plethysmography
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Support Ventilator | Active comparator | Device: Servo-i® ventilator, MAQUET,Critical Care, SwedenGold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). During pressure support the inspiratory muscles are assisted by a constant inspiratory pressure adjusted by the prescriptor and applied to the airway by either an invasive or a non invasive interface. Then the subject initiate the inspiratory effort and a constant pressure is delivered to the airway in order to assist inspiration. Three levels of pressure will be tested (5 cmH2O, 8 cmH2O and 12 cmH2O) |
| NAVA | Experimental | Device: Servo-i® ventilator, MAQUET,Critical Care, SwedenSpontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram. Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). During NAVA the inspiratory muscles are assisted by a pressure which is proportional to this electrical activity. Then the subject initiate the inspiratory effort and a pressure proportional to the integrated EMG activity is delivered to the airway in order to assist inspiration. The adjustment of the level of NAVA (expressed in cmH2O/microvolt) will be adjusted in order to obtain a peak pressure similar to pressure support (5 cmH2O, 8 cmH2O and 12 cmH2O) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Healthy Subject without any chronic disease
Key exclusion criteria (2 listed)
- Absence of consent
- Pregnant
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 |
|---|---|---|
| Servo-i® ventilator, MAQUET,Critical Care, SwedenAlso: PSVElectrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). Subject will be ventilated with a mouthpiece interface. NAVA will be compared to Pressure Support using the same ventilator. Once the pattern of breathing will be stabilized (10 minutes) in each condition (see arm) the following parameters will be recorded during 5 minutes and compared : tidal volume, inspiratory time, expiratory time, transcutaneous CO2 pressure, diaphragmatic Emg activity, delay between the inspiratory activity initiation and positive pressure initiation, delay between the end of the inspiratory effort and the end of pressurisation. | Device | NAVA, Pressure Support Ventilator |
Primary outcome
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time frame: 2h
2 secondary outcomes
Tidal volume evaluated by optoelectronic plethysmography
Time frame: 2h
Electrical diaphragmatic activity recorded by mechanical ventilator
Time frame: 2h
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 12 Apr 2013.
- Derived from this study: PubMed 24508509Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.
Related trials for Respiratory System Abnormalities
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Active, not recruitingObservational study
Genetic Modifiers of Cystic Fibrosis (CF) Liver Disease
Cystic Fibrosis, Liver Disease
RecruitingObservational study
Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
Infections, Pneumonia
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
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.
Frédéric Lofaso, MD-PhD principal investigator
Hopital Raymond Poincare - Garches - France
Nicolas Terzi, MD-PhD principal investigator
CHU de Caen - INSERM U1075 - France
Pascale Calabrese, PhD study director
Laboratoire TIMC-IMAG - La Tronche - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Servo-i® ventilator, MAQUET,Critical Care, Sweden in people with Respiratory System Abnormalities, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 2 inclusion and 2 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 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Comparison of breathing pattern during pressure support and Neurally Adjusted Ventilatory Assist (NAVA) (time frame: 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01614873, which also lists 1 linked publication.
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 12 Apr 2013.