Ventilator LungNCT06483529
Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique
A study testing compliance measurement in people with Ventilator Lung, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Respiratory failure has historically been one of the most important causes for admittance of patients to the critical care unit. This problem was the most important reason during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- compliance measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2023to 31 Dec 2024
- 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
- intubation
- Controlled ventilation with an intention to continue controlled ventilation for the following 4 hours.
- Richmond agitation sedation scale of -4 or less
- Hemodynamically stable patient with either
- unchanged vasopressor dose administration for at least 60 minutes before the start of the measurements
- no vasopressor need and no vasopressor initiated within 60 minutes of measurements
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- No planned intervention in the coming 2 hours
- Survival for at least 48 hours
- Protective ventilation (inspired oxygen concentration≤60%, plateau pressure ≤30 cmH2O , driving pressure≤ 15cmH2O)
- PEEP (Positive End Expiratory Pressure) ≤10
Who cannot join
- assist ventilation
- Ventilator asynchronies
- Intermittent spontaneous breathing
- nitric oxide therapy
- presence of an extra corporeal membrane oxygenation device
- Ventilation is not possible within the lower and upper inflection point of the low flow pressure volume curve.
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- Unstable right heart failure
- Unstable lung embolism
- Standard of care without Sedline® or invasive arterial catheter
- Do not reanimate code of 2, 3 or 4
- Subjects who are healthy, minors, pregnant women, patients in emergency situation
- Outside the age range 18 to 84 years
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussel Hoofstedelijk Gewest, 1090
Joop Jonckheer, MD, PhD, 028012679 ext. +32, joop.jonckheer@uzbrussel.be
About this study
Official title: Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique, an Explorative Study
Respiratory failure has historically been one of the most important causes for admittance of patients to the critical care unit. This problem was the most important reason during the COVID-19 pandemic. Following the evolution of the physiology of the lung has therefore been the number one concern during these challenging times in the intensive care unit (ICU). Respiratory oscillometry (RO) identifies the lung impedance by applying small pressure oscillations onto the breathing or ventilation. Information about the respiratory mechanics can be extracted out of this impedance, including the resistance (R) and compliance (C) of the lung. The VUB developed a robust, patient safe RO measurement protocol that delivers high quality measurements with the least possible interference with the patient's breathing/ventilation. The technique challenges current state-of-the-art techniques also aiming at identifying R and C of the respiratory system (not exclusively RO). The RO measurement protocol is in line with the technical standards of the ERS (European Respiratory Society) and has been successfully and safely tested on emulators and some parts on test subjects. The clinical investigation aims at a powered equivalence investigation between the RO measurement protocol and a standard of care dynamic compliance estimate on invasive ventilated patients. As secondary objectives, the feasibility of the RO techniques will be investigated during pressure support ventilation and the RO estimates will also be compared with other accepted respiratory mechanics estimation tools. To enable the investigation, a RO algorithm is developed, and a RO measurement extension is implemented in the DemcAir® ventilation system of Demcon. This was a fully tested ventilator that received a CE mark under the previous MDD regulation. However, Demcon, which produces ventilator parts for other commercial partners, removed the label to avoid competition with their partners. The ventilator will only execute the protocol on demand and save the data on an USB stick available in the ventilator. At any time, the RO measurement procedure can be stopped, and the ventilator will return to its initial ventilation. The USB stick is used to transport the data to a separate (VUB) laptop where the data processing is done.
- Conditions
- Ventilator Lung
- Being tested
- compliance measurement
- Keywords
- oscillometry, intensive care unit, intubated patients, compliance, resistance, impedance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliance measurementDiagnostic test
compliance can be measured by analyzing pressure volume curves generated through different methods
| Study group | Role | What they receive |
|---|---|---|
| ROELEC PROTOCOL | Experimental | ROELEC measurements consist of the application of a sine or multisine excitation pressure signal superimposed on the ventilation signal. The novelties are in the smart design of the excitation signal, not the way it is applied to the patient. Receives: Diagnostic Test: compliance measurement |
| dynamic P/V curves | Active comparator | dynamic ventilatory pressure volume curves generated during the standard ventilation settings Receives: Diagnostic Test: compliance measurement |
| low flow P/V curves | Other | static ventilatory pressure volume curves will be generated during the procedure to assure that the patients ventilation is between the lower inflection point and the higher inflection point. this P/V curves will also be analysed but will not be included in the primary endpoint analysis Receives: Diagnostic Test: compliance measurement |
| SOTA | Other | Standard of care oscillometry protocol will also generate low flow P/V curves but will not be included in the primary endpoint analysis Receives: Diagnostic Test: compliance measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance
compliance of the lung expressed in "ml/cmH20 "
Measured: Twice a day with at least 4hour interval, during 1 hour, compliance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
Secondary outcomes (2)
resistance
resistance of the lung expressed in cmH20/L/sec
Measured: Twice a day with at least 4hour interval, during 1 hour, resistance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
impedance
lung impedance expressed in Ohm
Measured: Twice a day with at least 4hour interval, during 1 hour, impedance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start18 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- prospective equivalence study with a two-arm crossover design - explorative pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- joop jonckheer, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483529
- Sponsor's protocol ID
- EC-2023-188-MDR
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Clinical Trial Summary Excel file and the .mat files can be shared safely on a request basis, given the anonymization scheme. This will allow other researchers to run their processing on the dataset and reach their own conclusions. The GDPR additional Excel file, or Mapping Table, and the eCRF will never be shared with anyone outside the principal investigator/authorized study member. With it, anyone can identify the patients who took part in the clinical trial.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Mechanics Measurement of Ventilated Patients Through Low-frequency Oscillometry Technique, an Explorative Study
- ClinicalTrials.gov ID
- NCT06483529
- Acronym / sponsor ID
- EC-2023-188-MDR
- Conditions
- Ventilator Lung
- Keywords
- oscillometry, intensive care unit, intubated patients, compliance, resistance, impedance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
Respiratory failure has historically been one of the most important causes for admittance of patients to the critical care unit. This problem was the most important reason during the COVID-19 pandemic. Following the evolution of the physiology of the lung has therefore been the number one concern during these challenging times in the intensive care unit (ICU). Respiratory oscillometry (RO) identifies the lung impedance by applying small pressure oscillations onto the breathing or ventilation. Information about the respiratory mechanics can be extracted out of this impedance, including the resistance (R) and compliance (C) of the lung. The VUB developed a robust, patient safe RO measurement protocol that delivers high quality measurements with the least possible interference with the patient's breathing/ventilation. The technique challenges current state-of-the-art techniques also aiming at identifying R and C of the respiratory system (not exclusively RO). The RO measurement protocol is in line with the technical standards of the ERS (European Respiratory Society) and has been successfully and safely tested on emulators and some parts on test subjects. The clinical investigation aims at a powered equivalence investigation between the RO measurement protocol and a standard of care dynamic compliance estimate on invasive ventilated patients. As secondary objectives, the feasibility of the RO techniques will be investigated during pressure support ventilation and the RO estimates will also be compared with other accepted respiratory mechanics estimation tools. To enable the investigation, a RO algorithm is developed, and a RO measurement extension is implemented in the DemcAir® ventilation system of Demcon. This was a fully tested ventilator that received a CE mark under the previous MDD regulation. However, Demcon, which produces ventilator parts for other commercial partners, removed the label to avoid competition with their partners. The ventilator will only execute the protocol on demand and save the data on an USB stick available in the ventilator. At any time, the RO measurement procedure can be stopped, and the ventilator will return to its initial ventilation. The USB stick is used to transport the data to a separate (VUB) laptop where the data processing is done.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- prospective equivalence study with a two-arm crossover design - explorative pilot study
| Arm | Type | Receives |
|---|---|---|
| ROELEC PROTOCOL | Experimental | Diagnostic Test: compliance measurementROELEC measurements consist of the application of a sine or multisine excitation pressure signal superimposed on the ventilation signal. The novelties are in the smart design of the excitation signal, not the way it is applied to the patient. |
| dynamic P/V curves | Active comparator | Diagnostic Test: compliance measurementdynamic ventilatory pressure volume curves generated during the standard ventilation settings |
| low flow P/V curves | Other | Diagnostic Test: compliance measurementstatic ventilatory pressure volume curves will be generated during the procedure to assure that the patients ventilation is between the lower inflection point and the higher inflection point. this P/V curves will also be analysed but will not be included in the primary endpoint analysis |
| SOTA | Other | Diagnostic Test: compliance measurementStandard of care oscillometry protocol will also generate low flow P/V curves but will not be included in the primary endpoint analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- intubation
- Controlled ventilation with an intention to continue controlled ventilation for the following 4 hours.
- Richmond agitation sedation scale of -4 or less
- Hemodynamically stable patient with either
- No planned intervention in the coming 2 hours
Key exclusion criteria (12 listed)
- assist ventilation
- Ventilator asynchronies
- Intermittent spontaneous breathing
- nitric oxide therapy
- presence of an extra corporeal membrane oxygenation 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 |
|---|---|---|
| compliance measurementcompliance can be measured by analyzing pressure volume curves generated through different methods | Diagnostic test | ROELEC PROTOCOL, SOTA, dynamic P/V curves, low flow P/V curves |
Primary outcome
compliance
Time frame: Twice a day with at least 4hour interval, during 1 hour, compliance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
compliance of the lung expressed in "ml/cmH20 "
2 secondary outcomes
resistance
Time frame: Twice a day with at least 4hour interval, during 1 hour, resistance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
impedance
Time frame: Twice a day with at least 4hour interval, during 1 hour, impedance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes. The Clinical Trial Summary Excel file and the .mat files can be shared safely on a request basis, given the anonymization scheme. This will allow other researchers to run their processing on the dataset and reach their own conclusions. The GDPR additional Excel file, or Mapping Table, and the eCRF will never be shared with anyone outside the principal investigator/authorized study member. With it, anyone can identify the patients who took part in the clinical trial.
Related trials for Ventilator Lung
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Ventilator-Induced Lung Injury, Sepsis Syndrome
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
joop jonckheer, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compliance measurement in people with Ventilator Lung, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 10 inclusion and 12 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 3 Jul 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 Belgium. 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 joop Jonckheer, MD, PhD (028012679 ext. +32, joop.jonckheer@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance (time frame: Twice a day with at least 4hour interval, during 1 hour, compliance will be measured in every interventional action: ROELEC protocol, SOTA, dynamic P/V curve and low flow P/V curve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.