PolyneuropathyPhase 1NCT00614562
Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Critical Illness Associated Polyneuropathy / or Polymyopathy (CIP/M)
A Phase 1 study testing Neurally adjusted ventilatory assist (NAVA) in people with Polyneuropathy and Polymyopathy, 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 NAVA in patients with critical illness associated polyneuropathy / polymyopathy (CIP/M) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polyneuropathy, Polymyopathy
- What is being tested?
- Neurally adjusted ventilatory assist (NAVA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Dec 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject itself or its next of kin has given written informed consent
- Independent physician has given written informed consent
- Male or female patients aged 18 - 80 years (extremes included).
- Mechanical ventilation for ≥ 48 hours prior to enrolment
- Presence of Critical Illness Polyneuropathy / Polymyopathy (CIP/M) according to the MRC Scale for Muscle Examination in 12 Muscle groups (Table 1) with or without loss of sensibility and muscle reflexes.
- Presence of at least one of the following risk factors (A - D) known to be associated with CIP/M. Note, the risk factor does not need to be present at enrolment but needs to have been present prior to enrolment during the actual stay in the ICU:
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- A: severe sepsis defined as the presence of an infection is highly suspected or proven and three or more of the following systemic inflammatory response syndrome (SIRS) criteria are met (Bernard et al 2001 s. Figure 15):
- core temperature greater than 38 degrees celsius (100.4 degrees F) or less than 36 degrees celsius (96.8 degrees F);
- heart rate greater than 90 beats per minute;
- respiratory rate greater than 20 breaths per minute, or arterial carbon dioxide tension (Paco2) greater than 32 mm Hg, or mechanical ventilation for an acute process;
- a white cell count of more than 12 000/mm3 or less than 4000/mm3 , or a differential count showing more than 10% immature neutrophils.
- B: MODS (s. Figure 15)
- C: treatment with corticosteroids for at least 24 hours (either as repeated bolus or as continuous infusion).
- D: treatment with neuro-muscular blocking agents for at least 24 hours (either as repeated bolus or as continuous infusion).
Who cannot join
- Patient is less than 18 years or more than 80 years of age
- The attending physician refuses to allow enrollment
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent
- The independent physician refuses informed consent
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age
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- 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, bleeding disorder with evidence of active bleeding.
- Presence or suspicion of diaphragm injury
- Presence or suspicion of a central nervous system (CNS) proximal of the spinal cord level C2) including (but not limited to): infarction, bleeding, tumor, or infection in the CNS
- Presence or suspicion of any preexisting peripheral neuromuscular disorder.
- 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 redefined tidal volume or airway pressure as per attending physician
- Severe hemodynamic instability as per attending physician
- A fraction of inspired oxygen (FiO2) of > 0.8 at enrollment.
- 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, 3010
About this study
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 NAVA in patients with critical illness associated polyneuropathy / polymyopathy (CIP/M)
- Conditions
- Polyneuropathy, Polymyopathy
- Being tested
- Neurally adjusted ventilatory assist (NAVA)
- Keywords
- critical associated illness polyneuropathy or polymyopathy (CIP/M)
- Medical subject headings
- Polyneuropathies
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
NAVA for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| NAVA | Experimental | Not described Receives: Device: Neurally adjusted ventilatory assist (NAVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean inspiratory electrical activity of the diaphragm (Edi)
Measured: beginning to end of study
Secondary outcomes (1)
Changes in ventilatory and respiratory parameters Changes in sedative and vasoactive drugs used
Measured: beginning to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionDec 2010
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 PolyneuropathyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00614562
- Sponsor's protocol ID
- KEK BE 250/07
- Status last verified
- Feb 2011
- First submitted
- 31 Jan 2008
- Last updated
- 3 Feb 2011
- 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 10581089Tuchscherer D, Z'graggen WJ, Passath C, Takala J, Sinderby C, Brander L. Neurally adjusted ventilatory assist in patients with critical illness-associated polyneuromyopathy. Intensive Care Med. 2011 Dec;37(12):1951-61. doi: 10.1007/s00134-011-2376-0. Epub 2011 Nov 3.
PubMed 22048718
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Critical Illness Associated Polyneuropathy / or Polymyopathy (CIP/M)
- ClinicalTrials.gov ID
- NCT00614562
- Acronym / sponsor ID
- KEK BE 250/07
- Conditions
- Polyneuropathy, Polymyopathy
- Keywords
- critical associated illness polyneuropathy or polymyopathy (CIP/M)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Feb 2008 (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 NAVA in patients with critical illness associated polyneuropathy / polymyopathy (CIP/M)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAVA | Experimental | Device: Neurally adjusted ventilatory assist (NAVA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject itself or its next of kin has given written informed consent
- Independent physician has given written informed consent
- Male or female patients aged 18 - 80 years (extremes included).
- Mechanical ventilation for ≥ 48 hours prior to enrolment
- Presence of Critical Illness Polyneuropathy / Polymyopathy (CIP/M) according to the MRC Scale for Muscle Examination in 12 Muscle groups (Table 1) with or without loss of sensibility and muscle reflexes.
Key exclusion criteria (17 listed)
- Patient is less than 18 years or more than 80 years of age
- The attending physician refuses to allow enrollment
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent
- The independent physician refuses informed consent
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)NAVA for 72 hours | Device | NAVA |
Primary outcome
Changes in mean inspiratory electrical activity of the diaphragm (Edi)
Time frame: beginning to end of study
1 secondary outcome
Changes in ventilatory and respiratory parameters Changes in sedative and vasoactive drugs used
Time frame: beginning to end of study
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 3 Feb 2011.
- 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 22048718Tuchscherer D, Z'graggen WJ, Passath C, Takala J, Sinderby C, Brander L. Neurally adjusted ventilatory assist in patients with critical illness-associated polyneuromyopathy. Intensive Care Med. 2011 Dec;37(12):1951-61. doi: 10.1007/s00134-011-2376-0. Epub 2011 Nov 3.
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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
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 Polyneuropathy and Polymyopathy, 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 14 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 3 Feb 2011. 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?
Changes in mean inspiratory electrical activity of the diaphragm (Edi) (time frame: beginning to end of study). 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 NCT00614562, 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 3 Feb 2011.