Respiratory FailurePhase 1NCT00647361
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance
A Phase 1 study testing Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). in people with Respiratory Failure and Cardiac Failure, 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 on cardiac performance in critically ill, mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure, Cardiac Failure
- What is being tested?
- Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).
- 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
- Mar 2008to Jun 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 - 85 years (extremes included)
- Mechanical ventilation (tracheally intubated or tracheotomized)
- Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg
- in 10 patients with impaired cardiac performance defined as either
- a left ventricular ejection fraction of < 40% and/or
- treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
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- a cardiac index of ≤ 2.2 L•min-1•m2 and/or
- a pulmonary artery occlusion pressure (PAOP) ≥ 18 mmHg
- in 10 patients with a history of chronic obstructive pulmonary disease (COPD) and delayed triggering-ON / cycling-OFF and/or evidence for wasted inspiratory efforts as evidenced by:
- limitation of expiratory air flow and intrinsic PEEP as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
- excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
- Presence of a pulmonary artery catheter and 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 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
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
- 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
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- 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 (including 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 MV controlling for tidal volume or for airway pressure as per attending physician.
- Severe hemodynamic instability as judged by the 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
Bern, Canton of Bern, 3010
About this study
Official title: Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance
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 on cardiac performance in critically ill, mechanically ventilated patients.
- Conditions
- Respiratory Failure, Cardiac Failure
- Being tested
- Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).
- Keywords
- respiratory insufficiency, respiration, ventilators, diaphragm, electromyography, mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency, Heart Failure, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).Device
Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
| Study group | Role | What they receive |
|---|---|---|
| NAVA | Experimental | Not described Receives: Device: Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac stroke volume index.
Measured: end of experimental periods
Secondary outcomes (1)
Global delivery of oxygen
Measured: end of experimental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionJun 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 Respiratory FailureStudies 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 - Inselspital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647361
- Sponsor's protocol ID
- KEK BE 217-06
- Status last verified
- Jul 2011
- First submitted
- 19 Mar 2008
- Last updated
- 19 Jul 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 10581089Berger D, Bloechlinger S, Takala J, Sinderby C, Brander L. Heart-lung interactions during neurally adjusted ventilatory assist. Crit Care. 2014 Sep 12;18(5):499. doi: 10.1186/s13054-014-0499-8.
PubMed 25212533
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance
- ClinicalTrials.gov ID
- NCT00647361
- Acronym / sponsor ID
- KEK BE 217-06
- Conditions
- Respiratory Failure, Cardiac Failure
- Keywords
- respiratory insufficiency, respiration, ventilators, diaphragm, electromyography, mechanical ventilation
- 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
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Mar 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 on cardiac performance in critically ill, mechanically ventilated patients.
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) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients aged 18 - 85 years (extremes included)
- Mechanical ventilation (tracheally intubated or tracheotomized)
- Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg
- Presence of a pulmonary artery catheter and 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 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
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
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) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV) | Device | NAVA |
Primary outcome
Cardiac stroke volume index.
Time frame: end of experimental periods
1 secondary outcome
Global delivery of oxygen
Time frame: end of experimental period
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 19 Jul 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 25212533Berger D, Bloechlinger S, Takala J, Sinderby C, Brander L. Heart-lung interactions during neurally adjusted ventilatory assist. Crit Care. 2014 Sep 12;18(5):499. doi: 10.1186/s13054-014-0499-8.
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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 - Inselspital, 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) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden). in people with Respiratory Failure and Cardiac Failure, 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 13 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 19 Jul 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?
Cardiac stroke volume index. (time frame: end of experimental periods). 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 NCT00647361, 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 19 Jul 2011.