Respiratory FailurePhase 1NCT01280383
Non-invasive Neurally Adjusted Ventilatory Assist
A Phase 1 study testing non-invasive neurally adjusted ventilatory assist in people with Respiratory Failure, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- non-invasive neurally adjusted ventilatory assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to May 2015
- 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
- Age 18 - 85 years
- History of chronic obstructive lung disease
- Invasive mechanical ventilation for more than 12 hours
- Planned extubation according to the weaning protocol of our clinic
- Informed consent obtained from a next of kin
- Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient
Who cannot join
- Tracheostomy
- Facial or cranial trauma or surgery
- Oral, esophageal, diaphragmatic or gastric trauma or surgery
- Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
- Uncooperative state and combativeness not responding to low levels of sedatives
- Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
- Next of kin refuses informed consent
- Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.
About this study
Official title: Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.
Read the detailed description
To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients
- Conditions
- Respiratory Failure
- Being tested
- non-invasive neurally adjusted ventilatory assist
- Keywords
- non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive neurally adjusted ventilatory assistDevice
Also called neurally adjusted ventilatory assist, non-invasive ventilation
non-invasive neurally adjusted ventilatory assist in critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| non-invasive NAVA | Experimental | application of non-invasive NAVA in critically ill patients Receives: Device: non-invasive neurally adjusted ventilatory assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-ventilator synchrony
Measured: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes
Secondary outcomes (1)
changes in respiratory pattern
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Study does not meet the new legal requirements set forth in the Human Research Act
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 FailureStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Brander, MD, Principal investigator, University Hospital (Inselspital) and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280383
- Sponsor's protocol ID
- BE KEK 123/10
- Status last verified
- Jul 2015
- First submitted
- 10 Jan 2011
- Last updated
- 23 Jul 2015
- 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 10581089
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT01280383
- Acronym / sponsor ID
- BE KEK 123/10
- Conditions
- Respiratory Failure
- Keywords
- non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study does not meet the new legal requirements set forth in the Human Research Act
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Jan 2011 (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 assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.
Detailed description
To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-invasive NAVA | Experimental | Device: non-invasive neurally adjusted ventilatory assistapplication of non-invasive NAVA in critically ill patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 85 years
- History of chronic obstructive lung disease
- Invasive mechanical ventilation for more than 12 hours
- Planned extubation according to the weaning protocol of our clinic
- Informed consent obtained from a next of kin
Key exclusion criteria (8 listed)
- Tracheostomy
- Facial or cranial trauma or surgery
- Oral, esophageal, diaphragmatic or gastric trauma or surgery
- Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
- Uncooperative state and combativeness not responding to low levels of sedatives
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 |
|---|---|---|
| non-invasive neurally adjusted ventilatory assistAlso: neurally adjusted ventilatory assist, non-invasive ventilationnon-invasive neurally adjusted ventilatory assist in critically ill patients | Device | non-invasive NAVA |
Primary outcome
patient-ventilator synchrony
Time frame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes
1 secondary outcome
changes in respiratory pattern
Time frame: study duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- 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.
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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.
Lukas Brander, MD principal investigator
University Hospital (Inselspital) and University of Bern
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing non-invasive neurally adjusted ventilatory assist in people with Respiratory Failure, run by Insel Gruppe AG, University Hospital Bern.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
patient-ventilator synchrony (time frame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes). 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 NCT01280383, 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 23 Jul 2015.