Post-cardiac SurgeryNCT05644418
EIT During FCV in the Intensive Care Unit
A study of Post-cardiac Surgery, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-cardiac Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Feb 2022to 9 May 2023
- 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
- 18 years or older;
- Informed consent form signed by the subject or a legal representative;
- Controlled mechanical ventilation via an endotracheal tube -
- FiO2 ≤50% and PEEP 10 cmH2O or lower
Who cannot join
- Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
- Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of <100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS
- Untreated pneumothorax (i.e. no pleural drainage)
- Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose >0.4mg/kg/min
- Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)
- Thoracic wounds, bandages or other obstruction which prevent proper functioning of the EIT device
- High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
- An inner tube diameter of 6mm or less
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit
The goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.
The main questions it aims to answer are:
Read more
- What is the effect of FCV on the lung volume measured by Electrical Impedance Tomography (EIT)?
- What is the effect of FCV on the minute volume?
- What is the effect of FCV on the mechanical power and dissipated energy?
Participants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.
- Conditions
- Post-cardiac Surgery
- Being tested
- Flow Controlled Ventilation (FCV)
- Keywords
- FCV, EIT, Mechanical Power, Minute volume, Dissipated energy, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Controlled Ventilation (FCV)Device
FCV is started with the same settings as PCV (PEEP, Ppeak, FiO2) and after 30 minutes FCV is optimized concerning the driving pressure and PEEP using the dynamic compliance. After a total of 60 minutes the flow is adjusted based on the arterial blood gas.
| Study group | Role | What they receive |
|---|---|---|
| Postcardiac surgery ICU-patients | Experimental | After postcardiac surgery patients are brought to the ICU and are ventilated on PCV (Pressure Controlled Ventilation). Measurements of the lung volume (by Electrical Impedance Tomography; EIT), the minute volume and Mechanical Power/Dissipated energy are started and continued for the duration of the study. After a few minutes the patient is switched to FCV (Flow Controlled Ventilation) for 90 minutes and afterwards PCV is resumed with the measurements lasting for another 30 minutes (total study time 120 minutes). Receives: Device: Flow Controlled Ventilation (FCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory lung volume
The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline
Measured: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)
Secondary outcomes (3)
Minute volume
The difference in minute volume between PCV and FCV with a stable PaCO2
Measured: The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV)
Mechanical Power
The difference in Mechanical Power between PCV and FCV are measured by using our own produced Pressure-Volume loops
Measured: The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
Dissipated energy
The difference in Dissipated energy between PCV and FCV are measured by using our own produced Pressure-Volume loops
Measured: The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start22 Feb 2022
- Primary completion9 May 2023
- Study completion9 May 2023
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 Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ventinova
- Responsible party
- Principal investigator, Henrik Endeman, Erasmus Medical Center
- Investigators
- Henrik Endeman, MD, PhD, Principal investigator, Erasmus MC, Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644418
- Sponsor's protocol ID
- NL 68962.078.19
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.
PubMed 38502268
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography During Flow Controlled Ventilation in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05644418
- Acronym / sponsor ID
- NL 68962.078.19
- Conditions
- Post-cardiac Surgery
- Keywords
- FCV, EIT, Mechanical Power, Minute volume, Dissipated energy, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Ventinova
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 9 Dec 2022 (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 goal of this clinical trial is to study the effects of Flow Controlled Ventilation (FCV) following conventional mechanical ventilation (Pressure or Volume Controlled Ventilation) in postcardiac surgery ICU-patients to allow for future power calculations and to obtain experience with FCV.
The main questions it aims to answer are:
- What is the effect of FCV on the lung volume measured by Electrical Impedance Tomography (EIT)?
- What is the effect of FCV on the minute volume?
- What is the effect of FCV on the mechanical power and dissipated energy?
Participants will be ventilated with PCV at baseline and then switched to FCV for 90 minutes while the lung volume, minute volume and mechanical power and dissipated energy levels are measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PCV at baseline, followed by 90 minutes of FCV and finished with 30 minutes of PCV
| Arm | Type | Receives |
|---|---|---|
| Postcardiac surgery ICU-patients | Experimental | Device: Flow Controlled Ventilation (FCV)After postcardiac surgery patients are brought to the ICU and are ventilated on PCV (Pressure Controlled Ventilation). Measurements of the lung volume (by Electrical Impedance Tomography; EIT), the minute volume and Mechanical Power/Dissipated energy are started and continued for the duration of the study. After a few minutes the patient is switched to FCV (Flow Controlled Ventilation) for 90 minutes and afterwards PCV is resumed with the measurements lasting for another 30 minutes (total study time 120 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older;
- Informed consent form signed by the subject or a legal representative;
- Controlled mechanical ventilation via an endotracheal tube -
- FiO2 ≤50% and PEEP 10 cmH2O or lower
Key exclusion criteria (8 listed)
- Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
- Severe respiratory insufficiency defined as a PaO2 to FiO2 ratio of <100mmHg or moderate to severe ARDS according to the Berlin definition of ARDS
- Untreated pneumothorax (i.e. no pleural drainage)
- Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose >0.4mg/kg/min
- Excessive subcutaneous emphysema (prevents proper functioning of the EIT device)
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 |
|---|---|---|
| Flow Controlled Ventilation (FCV)FCV is started with the same settings as PCV (PEEP, Ppeak, FiO2) and after 30 minutes FCV is optimized concerning the driving pressure and PEEP using the dynamic compliance. After a total of 60 minutes the flow is adjusted based on the arterial blood gas. | Device | Postcardiac surgery ICU-patients |
Primary outcome
End-expiratory lung volume
Time frame: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)
The difference in End-expiratory lung volume (EELV) between PCV and FCV is measured using the difference in End-expiratory lung impedance (EELI) and tidal volume at baseline
3 secondary outcomes
Minute volume
Time frame: The difference in minute volume between PCV at baseline and after 90 minutes of FCV (after optimization of FCV)
Mechanical Power
Time frame: The difference in Mechanical Power between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
Dissipated energy
Time frame: The difference in Dissipated energy between PCV at baseline and after 90 minutes of FCV (after FCV optimization)
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 12 Jan 2024.
- Derived from this study: PubMed 38502268Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.
- 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.
Henrik Endeman, MD, PhD principal investigator
Erasmus MC, Rotterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Post-cardiac Surgery, run by Erasmus Medical Center at 1 site in Netherlands.
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 8 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 12 Jan 2024. 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 Netherlands. 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?
End-expiratory lung volume (time frame: Baseline EELV compared to after 30 minutes of FCV (same ventilator settings)). 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 NCT05644418, 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 12 Jan 2024.