Neuro-intensive Care Unit PatientsNCT07585019
Ventilator Study in the NICU
A study testing Capnodynamic method in people with Neuro-intensive Care Unit Patients, run by Håkan Björne at 1 site in Sweden.
Trial summary
Background: Optimal adjustment of mechanical ventilation in intensive care patients is crucial to ensure effective ventilation and to reduce the risk of ventilator-associated complications such as pneumonia and ventilator-induced lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro-intensive Care Unit Patients
- What is being tested?
- Capnodynamic method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Stable with regard to intracranial pressure
- Hemodynamically stable
Who cannot join
- Ongoing instability with regard to intracranial pressure and circulation
- Spontaneous breathing / patient-triggered ventilation
- If the patient subsequently declines consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska University Hospital, Neurointensive care unit
Stockholm
Håkan Björne, Docent, +46812374719, hakan.bjorne@regionstockholm.se
About this study
Official title: Titration of End-expiratory Lung Volume Using the Capnodynamic Method in Intubated Neurointensive Care Patients - Effects on Driving Pressure, Compliance, and Mixed Venous Oxygen Saturation
Background:
Optimal adjustment of mechanical ventilation in intensive care patients is crucial to ensure effective ventilation and to reduce the risk of ventilator-associated complications such as pneumonia and ventilator-induced lung injury. Current monitoring methods may often be insufficient to achieve truly optimal ventilator settings in routine clinical practice. By applying a specific breathing pattern, additional key ventilation-related parameters can be monitored and adjusted using a novel carbon dioxide-based method. This approach has the potential to substantially improve ventilation in critically ill patients.
Read more
The carbon dioxide-based method utilizes a modified intensive care ventilator (Servo-i®, Getinge) equipped with CE-marked research software. The software modifies the breathing pattern by introducing three slightly prolonged expiratory pauses in three out of nine breaths. This ventilator has been used in multiple large-animal studies and clinical trials, including two conducted by the present research group.
Study Design:
The study will include adult patients receiving mechanical ventilation in a neurointensive care unit due to brain injury. Patients must be in a stable phase with regard to neurological status and circulation and require controlled mechanical ventilation. Informed consent will be obtained from the patient after recovery when applicable.
Part 1 (Pilot Study):
This is an observational study including 15 patients, aiming to establish reference values for parameters obtained using the carbon dioxide-based method, such as end-expiratory lung volume and mixed venous oxygen saturation. Patients will be switched to the research ventilator for 15-20 minutes, during which measurements from the carbon dioxide-based method and standard vital sign monitoring will be collected. Ventilator settings will be identical to those used on the patient's conventional ventilator. After completion of the protocol, patients will be switched back to their standard ventilator.
Part 2 (Main Study):
This is an interventional study with a within-subject (self-controlled) design, including 15 mechanically ventilated patients with stable brain injury. The aim is to optimize ventilator settings using the carbon dioxide-based method to achieve more lung-protective ventilation.
Patients will be transferred to the research ventilator using the same procedure as in the pilot study, initially maintaining the same ventilator settings. After a 10-minute stabilization period, ventilatory parameters will be recorded and an arterial blood gas sample obtained (baseline). The specific breathing pattern will then be initiated, and ventilation will be adjusted based on additional parameters provided by the capnodynamic method (end-expiratory lung volume, cardiac output, and mixed venous oxygen saturation). Measurements and arterial blood gases will be repeated immediately after initiation of the breathing pattern and again 15 minutes after ventilator adjustments. The study will then conclude, and the patient will be returned to their standard ventilator using the optimized ventilator settings to potentially ensure patient benefit.
Read the detailed description
The primary outcome measure is a reduction in driving pressure, as it is well established that a driving pressure >15 cmH₂O is associated with an increased risk of lung injury (ventilator-induced lung injury, VILI). Clinical observations in the intended study population show driving pressures of approximately 19 cmH₂O with an estimated standard deviation of 2 cmH₂O (study baseline). When these values are entered into a power calculation for a paired two-sided t-test, a sample size of approximately 10 patients is obtained. To account for potential dropouts, the study group size is set at 15 patients. The significance level is <0.05, with a power of 80%.
- Conditions
- Neuro-intensive Care Unit Patients
- Being tested
- Capnodynamic method
- Keywords
- mechanical ventilation, capnodynamic method, VILI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnodynamic methodDevice
Applying the capnodynamic method using a modified intensive care ventilator and subsequently use additional parameters like effective lung volume (ELV) in order to adjust ventilator settings to minimize driving pressure.
| Study group | Role | What they receive |
|---|---|---|
| Single group vetilation arm, both for pilot and main study | Experimental | Intervention i main study will be adjusting ventilator settings using capnodynamic parameters to minimize driving pressure. Receives: Device: Capnodynamic method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure (deltaP) cmH2O.
Difference in driving pressure (dP) before and after ventilatory adjustments.
Measured: Study protocols will have a time frame och 15-30 minutes.
Secondary outcomes (1)
ELV (ml)
Normal values of effective lung volume (ELV) with patients int 30 degrees head up position.
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (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 Neuro-intensive Care Unit PatientsStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Håkan Björne
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Håkan Björne, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585019
- Sponsor's protocol ID
- CIV-ID CIV-26-01-055996
- Other IDs
- 2026-01383-01
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iavarone IG, Rocco PRM, Grieco DL, Rosa T, Pellegrini M, Badenes R, Stevens RD, Asehnoune K, Robba C, Camporota L, Roquilly A. Pathophysiology and clinical applications of PEEP in acute brain injury. Intensive Care Med. 2025 Nov;51(11):2104-2116. doi: 10.1007/s00134-025-08111-9. Epub 2025 Sep 22.
PubMed 40982016Sigmundsson TS, Ohman T, Hallback M, Suarez-Sipmann F, Wallin M, Oldner A, Hallsjo-Sander C, Bjorne H. Comparison between capnodynamic and thermodilution method for cardiac output monitoring during major abdominal surgery: An observational study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1242-1252. doi: 10.1097/EJA.0000000000001566.
PubMed 34155171Ohman T, Sigmundsson TS, Hallback M, Suarez Sipmann F, Wallin M, Oldner A, Bjorne H, Hallsjo Sander C. Clinical and experimental validation of a capnodynamic method for end-expiratory lung volume assessment. Acta Anaesthesiol Scand. 2020 May;64(5):670-676. doi: 10.1111/aas.13552. Epub 2020 Jan 30.
PubMed 31965563Sander CH, Sigmundsson T, Hallback M, Sipmann FS, Wallin M, Oldner A, Bjorne H. A modified breathing pattern improves the performance of a continuous capnodynamic method for estimation of effective pulmonary blood flow. J Clin Monit Comput. 2017 Aug;31(4):717-725. doi: 10.1007/s10877-016-9891-z. Epub 2016 Jun 1.
PubMed 27251701Hallsjo Sander C, Hallback M, Suarez Sipmann F, Wallin M, Oldner A, Bjorne H. A novel continuous capnodynamic method for cardiac output assessment in a porcine model of lung lavage. Acta Anaesthesiol Scand. 2015 Sep;59(8):1022-31. doi: 10.1111/aas.12559. Epub 2015 Jun 4.
PubMed 26041115Hallsjo Sander C, Hallback M, Wallin M, Emtell P, Oldner A, Bjorne H. Novel continuous capnodynamic method for cardiac output assessment during mechanical ventilation. Br J Anaesth. 2014 May;112(5):824-31. doi: 10.1093/bja/aet486. Epub 2014 Feb 18.
PubMed 24554544
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration of End-expiratory Lung Volume Using the Capnodynamic Method in Intubated Neurointensive Care Patients - Effects on Driving Pressure, Compliance, and Mixed Venous Oxygen Saturation
- ClinicalTrials.gov ID
- NCT07585019
- Acronym / sponsor ID
- CIV-ID CIV-26-01-055996
- Conditions
- Neuro-intensive Care Unit Patients
- Keywords
- mechanical ventilation, capnodynamic method, VILI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Håkan BjörneOther government
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 May 2026 (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.
Background:
Optimal adjustment of mechanical ventilation in intensive care patients is crucial to ensure effective ventilation and to reduce the risk of ventilator-associated complications such as pneumonia and ventilator-induced lung injury. Current monitoring methods may often be insufficient to achieve truly optimal ventilator settings in routine clinical practice. By applying a specific breathing pattern, additional key ventilation-related parameters can be monitored and adjusted using a novel carbon dioxide-based method. This approach has the potential to substantially improve ventilation in critically ill patients.
The carbon dioxide-based method utilizes a modified intensive care ventilator (Servo-i®, Getinge) equipped with CE-marked research software. The software modifies the breathing pattern by introducing three slightly prolonged expiratory pauses in three out of nine breaths. This ventilator has been used in multiple large-animal studies and clinical trials, including two conducted by the present research group.
Study Design:
The study will include adult patients receiving mechanical ventilation in a neurointensive care unit due to brain injury. Patients must be in a stable phase with regard to neurological status and circulation and require controlled mechanical ventilation. Informed consent will be obtained from the patient after recovery when applicable.
Part 1 (Pilot Study):
This is an observational study including 15 patients, aiming to establish reference values for parameters obtained using the carbon dioxide-based method, such as end-expiratory lung volume and mixed venous oxygen saturation. Patients will be switched to the research ventilator for 15-20 minutes, during which measurements from the carbon dioxide-based method and standard vital sign monitoring will be collected. Ventilator settings will be identical to those used on the patient's conventional ventilator. After completion of the protocol, patients will be switched back to their standard ventilator.
Part 2 (Main Study):
This is an interventional study with a within-subject (self-controlled) design, including 15 mechanically ventilated patients with stable brain injury. The aim is to optimize ventilator settings using the carbon dioxide-based method to achieve more lung-protective ventilation.
Patients will be transferred to the research ventilator using the same procedure as in the pilot study, initially maintaining the same ventilator settings. After a 10-minute stabilization period, ventilatory parameters will be recorded and an arterial blood gas sample obtained (baseline). The specific breathing pattern will then be initiated, and ventilation will be adjusted based on additional parameters provided by the capnodynamic method (end-expiratory lung volume, cardiac output, and mixed venous oxygen saturation). Measurements and arterial blood gases will be repeated immediately after initiation of the breathing pattern and again 15 minutes after ventilator adjustments. The study will then conclude, and the patient will be returned to their standard ventilator using the optimized ventilator settings to potentially ensure patient benefit.
Detailed description
The primary outcome measure is a reduction in driving pressure, as it is well established that a driving pressure >15 cmH₂O is associated with an increased risk of lung injury (ventilator-induced lung injury, VILI). Clinical observations in the intended study population show driving pressures of approximately 19 cmH₂O with an estimated standard deviation of 2 cmH₂O (study baseline). When these values are entered into a power calculation for a paired two-sided t-test, a sample size of approximately 10 patients is obtained. To account for potential dropouts, the study group size is set at 15 patients. The significance level is <0.05, with a power of 80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group vetilation arm, both for pilot and main study | Experimental | Device: Capnodynamic methodIntervention i main study will be adjusting ventilator settings using capnodynamic parameters to minimize driving pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable with regard to intracranial pressure
- Hemodynamically stable
Key exclusion criteria (3 listed)
- Ongoing instability with regard to intracranial pressure and circulation
- Spontaneous breathing / patient-triggered ventilation
- If the patient subsequently declines 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 |
|---|---|---|
| Capnodynamic methodApplying the capnodynamic method using a modified intensive care ventilator and subsequently use additional parameters like effective lung volume (ELV) in order to adjust ventilator settings to minimize driving pressure. | Device | Single group vetilation arm, both for pilot and main study |
Primary outcome
Driving pressure (deltaP) cmH2O.
Time frame: Study protocols will have a time frame och 15-30 minutes.
Difference in driving pressure (dP) before and after ventilatory adjustments.
1 secondary outcome
ELV (ml)
Time frame: 15-30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 40982016Iavarone IG, Rocco PRM, Grieco DL, Rosa T, Pellegrini M, Badenes R, Stevens RD, Asehnoune K, Robba C, Camporota L, Roquilly A. Pathophysiology and clinical applications of PEEP in acute brain injury. Intensive Care Med. 2025 Nov;51(11):2104-2116. doi: 10.1007/s00134-025-08111-9. Epub 2025 Sep 22.
- Background: PubMed 34155171Sigmundsson TS, Ohman T, Hallback M, Suarez-Sipmann F, Wallin M, Oldner A, Hallsjo-Sander C, Bjorne H. Comparison between capnodynamic and thermodilution method for cardiac output monitoring during major abdominal surgery: An observational study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1242-1252. doi: 10.1097/EJA.0000000000001566.
- Background: PubMed 31965563Ohman T, Sigmundsson TS, Hallback M, Suarez Sipmann F, Wallin M, Oldner A, Bjorne H, Hallsjo Sander C. Clinical and experimental validation of a capnodynamic method for end-expiratory lung volume assessment. Acta Anaesthesiol Scand. 2020 May;64(5):670-676. doi: 10.1111/aas.13552. Epub 2020 Jan 30.
- Background: PubMed 27251701Sander CH, Sigmundsson T, Hallback M, Sipmann FS, Wallin M, Oldner A, Bjorne H. A modified breathing pattern improves the performance of a continuous capnodynamic method for estimation of effective pulmonary blood flow. J Clin Monit Comput. 2017 Aug;31(4):717-725. doi: 10.1007/s10877-016-9891-z. Epub 2016 Jun 1.
- Background: PubMed 26041115Hallsjo Sander C, Hallback M, Suarez Sipmann F, Wallin M, Oldner A, Bjorne H. A novel continuous capnodynamic method for cardiac output assessment in a porcine model of lung lavage. Acta Anaesthesiol Scand. 2015 Sep;59(8):1022-31. doi: 10.1111/aas.12559. Epub 2015 Jun 4.
- Background: PubMed 24554544Hallsjo Sander C, Hallback M, Wallin M, Emtell P, Oldner A, Bjorne H. Novel continuous capnodynamic method for cardiac output assessment during mechanical ventilation. Br J Anaesth. 2014 May;112(5):824-31. doi: 10.1093/bja/aet486. Epub 2014 Feb 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capnodynamic method in people with Neuro-intensive Care Unit Patients, run by Håkan Björne 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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Håkan Björne, Docent (+46812374719, hakan.bjorne@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving pressure (deltaP) cmH2O. (time frame: Study protocols will have a time frame och 15-30 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 NCT07585019, 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 13 May 2026.