Mechanical VentilationNCT04249414
Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
An observational study of Mechanical Ventilation and Ventilation Perfusion Mismatch, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
Trial summary
Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation, Ventilation Perfusion Mismatch
- What is being tested?
- PulmoVista 500
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2024to Dec 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the ICU who are mandatorily ventilated for at least 48 hours.
Who may be able to join
- Age 18 - 80 years
- Mandatorily ventilated intensive-care patients with impairment in oxygenation (P/F ratio < 300 at PEEP ≥ 5) ventilated at a positive end-expiratory pressure (PEEP) not exceeding 10 mbar and an fraction of inspired oxygen (FiO2) chosen, such that pulse oximetry is sensitive towards arterial oxygen pressure (PaO2) changes.
- Expected ventilation time >48h
- Existing central venous and arterial access
- Chest circumference 70 - 150 cm
- Mandatory mechanical ventilation (patients without spontaneous efforts)
- Serum levels of sodium and chloride within normal range
- Cardiac output monitoring in place (PICCO)
Who cannot join
- Contraindication to central venous injection of 5 % sodium chloride (NaCl) (e.g. elevated Na+ and/or Cl- concentration: Na+ should not exceed 150 mmol/l, Chloride should not exceed 115 mmol/l, known hypernatremia, known high serum osmolality)
- Contraindications of PulmoVista 500:
- Patients with pacemakers, defibrillators or other electrically active implants
- Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings
- Patients where the attachment of the patient belt could pose a risk to the patient, e.g. patients with spinal lesions or fractures
- Patients with uncontrolled body movements
Show all 13Show fewer
- Extremely obese patients (BMI>50)
- Patients during pregnancy
- Patients with massive lung edema
- Use during electricity-based therapies, such as electrosurgery or electrocautery
- Use in the presence of strong magnetic fields
- Use in conjunction with other bioimpedance measurement devices
- Infection or colonization with multi-resistant pathogens that require isolation of the patient (e.g. MRSA)
Trial locations and contacts
1 site in 1 country.
About this study
Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.
Read the detailed description
The results of this study will help defining the capability and reliability of PulmoVista® 500 (PV500) to detect changes in both global and regional ventilation and perfusion. As this is a non-invasive, observational trial, neither a positive nor a negative impact on the actual study participants is expected. The results will, however, improve the knowledge about the electrical impedance tomography (EIT) technology and thus aid the use of this technology for the benefit of future patients.
- Being tested
- PulmoVista 500
- Keywords
- Ventilation Monitoring, Electrical Impedance Tomography, Perfusion Monitoring, Hemodynamic Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulmoVista 500Device
Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine.
No medical interventions required
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess regional distribution of pulmonary perfusion
The capability of PulmoVista® 500 for assessing regional distribution of pulmonary perfusion based on pulsatility signals and based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
Measured: within 24 hours
Secondary outcomes (4)
Assess hemodynamic parameter cardiac output
The capability of PulmoVista® 500 for assessing cardiac output (relative values compared to reference given in l/min) will be explored.
Measured: within 24 hours
Assess hemodynamic parameter heart rate
The capability of PulmoVista® 500 for assessing heart rate (1/min) will be explored.
Measured: within 24 hours
Assess hemodynamic parameter stroke volume variability
The capability of PulmoVista® 500 for assessing stroke volume variability (relative value in % for 30 seconds compared to reference given in ml) will be explored.
Measured: within 24 hours
Assess oxygenation status
The capability PulmoVista® 500 for assessing the oxygenation status from both the regional distribution of alveolar ventilation and the regional distribution of pulmonary perfusion will be explored.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startJan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Due to a lack of resources (human and financial), it is currently unclear if the study will be counducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drägerwerk AG & Co. KGaA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Göttingen, Prof. Dr. med. Imhoff
- Responsible party
- Sponsor
- Investigators
- Onnen Mörer, Prof. Dr., Principal investigator, Centre of Anaesthesiology University Medical Center GöttingenMichael Quintel, Prof. Dr., Study director, Centre of Anaesthesiology University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249414
- Sponsor's protocol ID
- PV500PERF
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT04249414
- Acronym / sponsor ID
- PV500PERF
- Keywords
- Ventilation Monitoring, Electrical Impedance Tomography, Perfusion Monitoring, Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to a lack of resources (human and financial), it is currently unclear if the study will be counducted.
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Drägerwerk AG & Co. KGaAIndustry (pharma, biotech, devices)
- Collaborators
- University of Göttingen, Prof. Dr. med. Imhoff
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2020 (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.
Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.
Detailed description
The results of this study will help defining the capability and reliability of PulmoVista® 500 (PV500) to detect changes in both global and regional ventilation and perfusion. As this is a non-invasive, observational trial, neither a positive nor a negative impact on the actual study participants is expected. The results will, however, improve the knowledge about the electrical impedance tomography (EIT) technology and thus aid the use of this technology for the benefit of future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the ICU who are mandatorily ventilated for at least 48 hours.
Key inclusion criteria (8 listed)
- Age 18 - 80 years
- Mandatorily ventilated intensive-care patients with impairment in oxygenation (P/F ratio < 300 at PEEP ≥ 5) ventilated at a positive end-expiratory pressure (PEEP) not exceeding 10 mbar and an fraction of inspired oxygen (FiO2) chosen, such that pulse oximetry is sensitive towards arterial oxygen pressure (PaO2) changes.
- Expected ventilation time >48h
- Existing central venous and arterial access
- Chest circumference 70 - 150 cm
Key exclusion criteria (13 listed)
- Contraindication to central venous injection of 5 % sodium chloride (NaCl) (e.g. elevated Na+ and/or Cl- concentration: Na+ should not exceed 150 mmol/l, Chloride should not exceed 115 mmol/l, known hypernatremia, known high serum osmolality)
- Contraindications of PulmoVista 500:
- Infection or colonization with multi-resistant pathogens that require isolation of the patient (e.g. MRSA)
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 |
|---|---|---|
| PulmoVista 500Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine. No medical interventions required | Device | – |
Primary outcome
Assess regional distribution of pulmonary perfusion
Time frame: within 24 hours
The capability of PulmoVista® 500 for assessing regional distribution of pulmonary perfusion based on pulsatility signals and based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.
4 secondary outcomes
Assess hemodynamic parameter cardiac output
Time frame: within 24 hours
Assess hemodynamic parameter heart rate
Time frame: within 24 hours
Assess hemodynamic parameter stroke volume variability
Time frame: within 24 hours
Assess oxygenation status
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- 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.
Onnen Mörer, Prof. Dr. principal investigator
Centre of Anaesthesiology University Medical Center Göttingen
Michael Quintel, Prof. Dr. study director
Centre of Anaesthesiology University Medical Center Göttingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Ventilation Perfusion Mismatch, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
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 8 inclusion and 13 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: paused, as of the sponsor's last update on 6 Mar 2023. 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 Germany. 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?
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?
Assess regional distribution of pulmonary perfusion (time frame: within 24 hours). 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 6 Mar 2023.