Mechanical VentilationPhase 1NCT00529347
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern
A Phase 1 study testing neurally adjusted ventilatory assist (NAVA) in people with Mechanical Ventilation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- neurally adjusted ventilatory assist (NAVA)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Jul 2009
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive mechanical ventilation (tracheally intubated or tracheotomized)
- Presence of an arterial pressure line.
- Subject itself or its next of kin has given written informed consent
Who cannot join
- Patient is less than 18 years or more than 85 years of age
- The attending physician refuses to allow enrollment
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.
- Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
Show all 17Show fewer
- Presence or suspicion of diaphragm injury
- Hemophilia or other severe bleeding disorder
- Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
- History of heart and/or lung transplantation
- Any mechanical cardiac assist device (excluding intraaortic balloon pump)
- Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
- The patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician
- Severe hemodynamic instability as per attending physician
- Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
- A fraction of inspired oxygen (FiO2) of > 0.8
- The patient currently participates in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care Medicine, University Hospital - Inselspital
Bern, Canton of Bern, 3010
About this study
Official title: The Effect of Positive End Expiratory Pressure (PEEP) on the Breathing Pattern During Neurally Adjusted Ventilatory Assist (NAVA)
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.
- Conditions
- Mechanical Ventilation
- Being tested
- neurally adjusted ventilatory assist (NAVA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurally adjusted ventilatory assist (NAVA)Device
assessment of breathing pattern at various ventilator settings
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragmatic Edi (area under the curve) during expiration
Measured: At each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Lukas Brander, MD, Principal investigator, Department of Intensive Care Medicine, University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529347
- Sponsor's protocol ID
- SNF-3200B0-113478-1
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2007
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
PubMed 10581089Passath C, Takala J, Tuchscherer D, Jakob SM, Sinderby C, Brander L. Physiologic response to changing positive end-expiratory pressure during neurally adjusted ventilatory assist in sedated, critically ill adults. Chest. 2010 Sep;138(3):578-87. doi: 10.1378/chest.10-0286. Epub 2010 Apr 30.
PubMed 20435654
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive End Expiratory Pressure (PEEP) on the Breathing Pattern During Neurally Adjusted Ventilatory Assist (NAVA)
- ClinicalTrials.gov ID
- NCT00529347
- Acronym / sponsor ID
- SNF-3200B0-113478-1
- Conditions
- Mechanical Ventilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Sep 2007 (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.
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Invasive mechanical ventilation (tracheally intubated or tracheotomized)
- Presence of an arterial pressure line.
- Subject itself or its next of kin has given written informed consent
Key exclusion criteria (17 listed)
- Patient is less than 18 years or more than 85 years of age
- The attending physician refuses to allow enrollment
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.
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 |
|---|---|---|
| neurally adjusted ventilatory assist (NAVA)assessment of breathing pattern at various ventilator settings | Device | – |
Primary outcome
Change in diaphragmatic Edi (area under the curve) during expiration
Time frame: At each intervention
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 9 Sep 2009.
- Background: PubMed 10581089Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
- Derived from this study: PubMed 20435654Passath C, Takala J, Tuchscherer D, Jakob SM, Sinderby C, Brander L. Physiologic response to changing positive end-expiratory pressure during neurally adjusted ventilatory assist in sedated, critically ill adults. Chest. 2010 Sep;138(3):578-87. doi: 10.1378/chest.10-0286. Epub 2010 Apr 30.
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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.
Lukas Brander, MD principal investigator
Department of Intensive Care Medicine, University Hospital, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neurally adjusted ventilatory assist (NAVA) in people with Mechanical Ventilation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 17 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 9 Sep 2009. 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 Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in diaphragmatic Edi (area under the curve) during expiration (time frame: At each intervention). 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 NCT00529347, which also lists 2 linked publications.
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 9 Sep 2009.