Acute Respiratory FailureNCT02711722
NAVA Unloading - Effects on Distribution of Ventilation
A study testing Neurally adjusted ventilatory assist, PScli1 and PScli2 in people with Acute Respiratory Failure, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients. Objectives: 1. To investigate if NAVA targeted to moderate respiratory muscular unloading results in redistribution of ventilation to the dorsal regions of the lungs 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Neurally adjusted ventilatory assist, PScli1 and PScli2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2015to Sep 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients belonging to Neurosurgical ICU
- Intubated for ≥48h
- Weaning phase from Mechanical Ventilation
Who cannot join
- bleeding disorders (PK INR>1,5 or APTT>50s or platelet count <50000/µL) or
- unstable intracranial pressure (ICP>20 mmHg during the latest 8 hours) or
- unstable circulation (requiring high vasopressor dose, for example Noradrenalin >0,2µg/kg/min) or
- too severe lung disease (PFI ≤ 26,7 kPa or PEEP >10 cmH2O or FiO2>0,5 at study entry point) or
- fever> 38,5°C or
- tendency to hyperventilation (PaCO2 < 4,5 kPa at study entry point).
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept. Anesthesiology, Surgical Services and Intensive Care Medicine,Karolinska Univeristy Hospital
Stockholm, 17176
Francesca Campoccia Jalde, MD, 0046703947741, francesca.campoccia-jalde@karolinska.se
Peter V Sackey, MD, PhD, +46851772066, peter.sackey@karolinska.se
About this study
Official title: Reduced Unloading in NAVA Improves Distribution of Ventilation in ICU Patients
Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients.
Objectives:
Read more
- To investigate if NAVA targeted to moderate respiratory muscular unloading results in redistribution of ventilation to the dorsal regions of the lungs
- To verify if the redistribution of ventilation translates to a better gas exchange and to a potentially lung protective ventilation strategy (lower airway pressures)
- To verify the possibility to set NAVA at different levels of unloading, based on Neuro-Ventilatory Efficiency.
Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of unloading.
Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h, in weaning phase from mechanical ventilation.
Study duration: 2,5h Number of subjects: 12
Read the detailed description
Critically ill patients on mechanical ventilation are at risk for developing respiratory muscle atrophy. Partial Assist modes such Pressure Support (PS) and Neurally Adjusted Ventilatory Assist (NAVA) are developed to maintain patients´own effort in breathing. However there are no recommendations on how to set the optimal ventilator support in NAVA to avoid over- or underassistance.
A previous Electrical Impedance Thomography (EIT) study has shown a redistribution of ventilation towards the dorsal regions of the lung in acute lung injury patients ventilated with NAVA, compared to PS.
In the present study, the assist is targeted to different respiratory muscle unloading, predefined and based on the Neuro-Ventilatory Efficiency (NVE). The NVE will be measured at 10min intervals and NAVA level adjusted if needed, to keep constant the level of unloading in each study step.
Protocol: Once enrolled, the patients are ventilated in PS (PScli1) as set by the clinician. They are then ventilated in NAVA at 3 different levels of muscle unloading in randomized order. At NAVAcli, the assist level matches to PScli1 in terms of muscle unloading. With NAVA40% and NAVA60%, the patients have 40% and 60% unloading, respectively. In the last study step the patients are back to PS (PScli2). Each patient is his/her own control and goes through the 5 ventilation periods, of 30min each. In the last 5 min of each study step, the CoV (obtained through the EIT data), blood gas samples (for oxygenation and ventilation) and ventilatory parameters are obtained and analyzed.
The investigators hypothesize that
- It is possible to set NAVA at different levels of unloading, based on NVE.
- Moderate muscle unloading (corresponding to NAVA40%) keeps the diaphragm active and thereby leads to more dorsal distribution of ventilation compared to PScli and to higher unloading in NAVA.
- Secondarily and as a consequence of the redistribution of ventilation, we hypothesize that the gas exchange will remain unchanged or will improve and that the airway pressures will decrease for moderate unloading (NAVA40%).
- Conditions
- Acute Respiratory Failure
- Being tested
- Neurally adjusted ventilatory assist, PScli1, PScli2
- Keywords
- Neurally adjusted ventilatory assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assistDevice
Also called NAVA
Ventilation supported by NAVA
- Blood gas analysis
- Respiratory Parameters At the end of the study step Neuro-Ventilatory Efficiency and Neuro-Mechanical Efficiency are measured.
PScli1Device
Also called Pressure support
Pressure support set by clinicians prior to inclusion
PScli2Device
Also called Pressure support
Pressure support at the same level as prior to the study
| Study group | Role | What they receive |
|---|---|---|
| PScli1 | Active comparator | Patients are ventilated in Pressure support (PS) according to the Clinical settings for 30min. Receives: Device: PScli1 |
| NAVAcli | Active comparator | Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to match to respiratory muscle unloading reached with PScli1. Patients are ventilated in NAVAcli for 30min. Receives: Device: Neurally adjusted ventilatory assist |
| NAVA40% | Active comparator | Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 40% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA40% for 30min. Receives: Device: Neurally adjusted ventilatory assist |
| NAVA60% | Active comparator | Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 60% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA60% for 30min. Receives: Device: Neurally adjusted ventilatory assist |
| PScli2 | Active comparator | Patients return to PS ventilation, according to the Clinical settings as in PScli1 for 30min. Receives: Device: PScli2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Ventilation (CoV), expressed in percent (ventral to dorsal)
The distribution of ventilation is summarized by the CoV, a parameter obtained by the EIT monitor. Recordings are made at the end of each study step (total 5), lasting 30min.
Measured: Total study time is 2,5 hours
Secondary outcomes (3)
Gas Exchange (PaO2 and PaCO2)
Comparison between study steps
Measured: During the last 5min of each study step (each 30min), total 5 steps. Total study time 2,5 hours
Airway Pressure
Measured: 2,5 hours
Muscle unloading based on Neuro-Ventilatory Efficiency and Neuro-Mechanica Efficiency
Measured: 2,5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Sackey, Karolinska University Hospital
- Investigators
- Peter V Sackey, MD, PhD, Study chair, Karolinska University HospitalFrancesca Campoccia Jalde, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711722
- Sponsor's protocol ID
- 2015/521-31/4
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Sinderby 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 10581089Blankman P, Hasan D, van Mourik MS, Gommers D. Ventilation distribution measured with EIT at varying levels of pressure support and Neurally Adjusted Ventilatory Assist in patients with ALI. Intensive Care Med. 2013 Jun;39(6):1057-62. doi: 10.1007/s00134-013-2898-8. Epub 2013 Apr 4.
PubMed 23553568Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451.
PubMed 22849707Grasselli G, Beck J, Mirabella L, Pesenti A, Slutsky AS, Sinderby C. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist. Intensive Care Med. 2012 Jul;38(7):1224-32. doi: 10.1007/s00134-012-2588-y. Epub 2012 May 15.
PubMed 22584798Liu L, Liu S, Xie J, Yang Y, Slutsky AS, Beck J, Sinderby C, Qiu H. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist in patients with acute respiratory failure. Crit Care. 2015 Feb 18;19(1):43. doi: 10.1186/s13054-015-0775-2.
PubMed 25882607
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Unloading in NAVA Improves Distribution of Ventilation in ICU Patients
- ClinicalTrials.gov ID
- NCT02711722
- Acronym / sponsor ID
- 2015/521-31/4
- Conditions
- Acute Respiratory Failure
- Keywords
- Neurally adjusted ventilatory assist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 17 Mar 2016 (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.
Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients.
Objectives:
- To investigate if NAVA targeted to moderate respiratory muscular unloading results in redistribution of ventilation to the dorsal regions of the lungs
- To verify if the redistribution of ventilation translates to a better gas exchange and to a potentially lung protective ventilation strategy (lower airway pressures)
- To verify the possibility to set NAVA at different levels of unloading, based on Neuro-Ventilatory Efficiency.
Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of unloading.
Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h, in weaning phase from mechanical ventilation.
Study duration: 2,5h Number of subjects: 12
Detailed description
Critically ill patients on mechanical ventilation are at risk for developing respiratory muscle atrophy. Partial Assist modes such Pressure Support (PS) and Neurally Adjusted Ventilatory Assist (NAVA) are developed to maintain patients´own effort in breathing. However there are no recommendations on how to set the optimal ventilator support in NAVA to avoid over- or underassistance.
A previous Electrical Impedance Thomography (EIT) study has shown a redistribution of ventilation towards the dorsal regions of the lung in acute lung injury patients ventilated with NAVA, compared to PS.
In the present study, the assist is targeted to different respiratory muscle unloading, predefined and based on the Neuro-Ventilatory Efficiency (NVE). The NVE will be measured at 10min intervals and NAVA level adjusted if needed, to keep constant the level of unloading in each study step.
Protocol: Once enrolled, the patients are ventilated in PS (PScli1) as set by the clinician. They are then ventilated in NAVA at 3 different levels of muscle unloading in randomized order. At NAVAcli, the assist level matches to PScli1 in terms of muscle unloading. With NAVA40% and NAVA60%, the patients have 40% and 60% unloading, respectively. In the last study step the patients are back to PS (PScli2). Each patient is his/her own control and goes through the 5 ventilation periods, of 30min each. In the last 5 min of each study step, the CoV (obtained through the EIT data), blood gas samples (for oxygenation and ventilation) and ventilatory parameters are obtained and analyzed.
The investigators hypothesize that
- It is possible to set NAVA at different levels of unloading, based on NVE.
- Moderate muscle unloading (corresponding to NAVA40%) keeps the diaphragm active and thereby leads to more dorsal distribution of ventilation compared to PScli and to higher unloading in NAVA.
- Secondarily and as a consequence of the redistribution of ventilation, we hypothesize that the gas exchange will remain unchanged or will improve and that the airway pressures will decrease for moderate unloading (NAVA40%).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PScli1 | Active comparator | Device: PScli1Patients are ventilated in Pressure support (PS) according to the Clinical settings for 30min. |
| NAVAcli | Active comparator | Device: Neurally adjusted ventilatory assistPatients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to match to respiratory muscle unloading reached with PScli1. Patients are ventilated in NAVAcli for 30min. |
| NAVA40% | Active comparator | Device: Neurally adjusted ventilatory assistPatients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 40% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA40% for 30min. |
| NAVA60% | Active comparator | Device: Neurally adjusted ventilatory assistPatients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 60% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA60% for 30min. |
| PScli2 | Active comparator | Device: PScli2Patients return to PS ventilation, according to the Clinical settings as in PScli1 for 30min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients belonging to Neurosurgical ICU
- Intubated for ≥48h
- Weaning phase from Mechanical Ventilation
Key exclusion criteria (6 listed)
- bleeding disorders (PK INR>1,5 or APTT>50s or platelet count <50000/µL) or
- unstable intracranial pressure (ICP>20 mmHg during the latest 8 hours) or
- unstable circulation (requiring high vasopressor dose, for example Noradrenalin >0,2µg/kg/min) or
- too severe lung disease (PFI ≤ 26,7 kPa or PEEP >10 cmH2O or FiO2>0,5 at study entry point) or
- fever> 38,5°C or
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 assistAlso: NAVAVentilation supported by NAVA * Blood gas analysis * Respiratory Parameters At the end of the study step Neuro-Ventilatory Efficiency and Neuro-Mechanical Efficiency are measured. | Device | NAVA40%, NAVA60%, NAVAcli |
| PScli1Also: Pressure supportPressure support set by clinicians prior to inclusion | Device | PScli1 |
| PScli2Also: Pressure supportPressure support at the same level as prior to the study | Device | PScli2 |
Primary outcome
Center of Ventilation (CoV), expressed in percent (ventral to dorsal)
Time frame: Total study time is 2,5 hours
The distribution of ventilation is summarized by the CoV, a parameter obtained by the EIT monitor. Recordings are made at the end of each study step (total 5), lasting 30min.
3 secondary outcomes
Gas Exchange (PaO2 and PaCO2)
Time frame: During the last 5min of each study step (each 30min), total 5 steps. Total study time 2,5 hours
Airway Pressure
Time frame: 2,5 hours
Muscle unloading based on Neuro-Ventilatory Efficiency and Neuro-Mechanica Efficiency
Time frame: 2,5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- 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.
- Background: PubMed 23553568Blankman P, Hasan D, van Mourik MS, Gommers D. Ventilation distribution measured with EIT at varying levels of pressure support and Neurally Adjusted Ventilatory Assist in patients with ALI. Intensive Care Med. 2013 Jun;39(6):1057-62. doi: 10.1007/s00134-013-2898-8. Epub 2013 Apr 4.
- Background: PubMed 22849707Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451.
- Background: PubMed 22584798Grasselli G, Beck J, Mirabella L, Pesenti A, Slutsky AS, Sinderby C. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist. Intensive Care Med. 2012 Jul;38(7):1224-32. doi: 10.1007/s00134-012-2588-y. Epub 2012 May 15.
- Background: PubMed 25882607Liu L, Liu S, Xie J, Yang Y, Slutsky AS, Beck J, Sinderby C, Qiu H. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist in patients with acute respiratory failure. Crit Care. 2015 Feb 18;19(1):43. doi: 10.1186/s13054-015-0775-2.
- Individual participant dataSharing planned: No
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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.
Peter V Sackey, MD, PhD study chair
Karolinska University Hospital
Francesca Campoccia Jalde, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally adjusted ventilatory assist, PScli1 and PScli2 in people with Acute Respiratory Failure, run by Karolinska University Hospital at 1 site in Sweden.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Apr 2016. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter V Sackey, MD, PhD (+46851772066, peter.sackey@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of Ventilation (CoV), expressed in percent (ventral to dorsal) (time frame: Total study time is 2,5 hours). 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 NCT02711722, which also lists 6 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 15 Apr 2016.