Ventilator LungNCT03217305
Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery
A study testing NAVA in people with Ventilator Lung, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- NAVA
- 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
- 30 Aug 2016to 2 Dec 2025
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complicated Post Cardiac surgery patients in the ventilator weaning phase.
- Patients requiring assisted ventilation
- Respiratory and circulatory stable patients
- Sedated patients, RASS -2 to -3
Who cannot join
- Transplanted patients
- Pleural effusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study
The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.
Read the detailed description
The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.
All patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).
- Conditions
- Ventilator Lung
- Being tested
- NAVA
- Keywords
- EIT. NAVA. Endexpiratory Lung Impedance.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| NAVA vs Pressure Support | Other | Control (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation distribution
Redistribution of ventilation , dorsally vs. ventrally
Measured: Through study completion, within approximately 18 months
Alveolar dead space
Calculated from blood gases and end tidal pCO2,using standard formulae
Measured: Through study completion, within approximately 18 months
End expiratory lung impedance
Measured by Electric Impedance Tomography
Measured: Through study completion, within approximately 18 months
PaO2/FiO2
Arterial oxygenation
Measured: Through study completion, within approximately 18 months
Alveolar shunt
Calculated from mixed venous and arterial blood gases
Measured: Through study completion, within approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start30 Aug 2016
- Primary completion30 Sep 2025
- Study completion2 Dec 2025
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 Ventilator LungStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Control-Intervention-Control
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Martinsson, Göteborg University
- Investigators
- Anders Thoren, MD, PhD, Principal investigator, University of Goteborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217305
- Sponsor's protocol ID
- AMartinssonthorax2
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinsson A, Lundholm C, Ricksten SE, Oras J, Magnusson JM, Wallinder A, Sellgren J, Thoren A. Neurally adjusted ventilatory assist vs pressure support ventilation: short-term effects on shunt and dead space after cardiac surgery. Sci Rep. 2025 Dec 21;15(1):44234. doi: 10.1038/s41598-025-33097-1.
PubMed 41423634
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study
- ClinicalTrials.gov ID
- NCT03217305
- Acronym / sponsor ID
- AMartinssonthorax2
- Conditions
- Ventilator Lung
- Keywords
- EIT. NAVA. Endexpiratory Lung Impedance.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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.
The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.
Detailed description
The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.
All patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Control-Intervention-Control
| Arm | Type | Receives |
|---|---|---|
| NAVA vs Pressure Support | Other | Device: NAVAControl (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complicated Post Cardiac surgery patients in the ventilator weaning phase.
- Patients requiring assisted ventilation
- Respiratory and circulatory stable patients
- Sedated patients, RASS -2 to -3
Key exclusion criteria (2 listed)
- Transplanted patients
- Pleural effusion.
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 |
|---|---|---|
| NAVANeurally Adjusted Ventilatory Assist is a fairly new ventilation mode | Device | NAVA vs Pressure Support |
Primary outcome
Ventilation distribution
Time frame: Through study completion, within approximately 18 months
Redistribution of ventilation , dorsally vs. ventrally
Alveolar dead space
Time frame: Through study completion, within approximately 18 months
Calculated from blood gases and end tidal pCO2,using standard formulae
End expiratory lung impedance
Time frame: Through study completion, within approximately 18 months
Measured by Electric Impedance Tomography
PaO2/FiO2
Time frame: Through study completion, within approximately 18 months
Arterial oxygenation
Alveolar shunt
Time frame: Through study completion, within approximately 18 months
Calculated from mixed venous and arterial blood gases
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 24 Apr 2026.
- Derived from this study: PubMed 41423634Martinsson A, Lundholm C, Ricksten SE, Oras J, Magnusson JM, Wallinder A, Sellgren J, Thoren A. Neurally adjusted ventilatory assist vs pressure support ventilation: short-term effects on shunt and dead space after cardiac surgery. Sci Rep. 2025 Dec 21;15(1):44234. doi: 10.1038/s41598-025-33097-1.
- 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.
Anders Thoren, MD, PhD principal investigator
University of Goteborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA in people with Ventilator Lung, run by Sahlgrenska 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 4 inclusion and 2 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 24 Apr 2026. 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?
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?
Ventilation distribution (time frame: Through study completion, within approximately 18 months). The study lists 5 primary outcomes in all. 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 NCT03217305, 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 24 Apr 2026.