Monitoring of Regional Distribution of VentilationPV500pedNCT04873999
Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)
An observational study of Monitoring of Regional Distribution of Ventilation and Monitoring of Lung Volume, run by Drägerwerk AG & Co. KGaA at 1 site in Germany.
Trial summary
This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients. The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle. Read more about this study
- Who is it for?
- Ages Up to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Monitoring of Regional Distribution of Ventilation, Monitoring of Lung Volume
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2021to 28 Jul 2021
- 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 Up to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients that visit the hospital for any kind of surgery, therefore requireing mechanical ventilation. Monitoring of Regional Distribution of Ventilation and Lung Volume are of clinical interest in these patients.
Who may be able to join
- Pediatric male or female patients excluding preterm infants
- Patients with a chest circumference between 36 and 72 cm
- Patients ≤ 12 years.
- Patients with a tidal volume > 20 ml, i.e., children with a body weight of more than 3.3 kg (assuming a targeted tidal volume of 6 mL/kg body weight)
- Patients for whom mechanical ventilation is intended
- Patients whose regional distribution of ventilation and of lung volume are of clinical interest
- Patients who are (should be) ventilated via an artificial airway access, whereby the ventilator used is compatible with PulmoVista 500
- Patients and / or their legal guardians or legal representatives who have given written informed consent to participate in the study
Who cannot join
- Patients who are supplied with a permanent or temporary pacemaker, an implantable defibrillator or other medical devices that emit electrical energy (e.g. cochlea amplifier implant)
- Patients with a tidal volume ≤ 20 ml
- Patients in whom the application of the electrode belt could be impaired by wound care or infections in the chest area
- Female patients for whom pregnancy cannot be excluded; a pregnancy test should be performed at the discretion of the investigator.
- Patients with an alleged allergic reaction to the materials of the electrode belt
- Patients with a Body Mass Index (BMI) > 40
- Evidence that suggests that the patient or their legal representative will not comply with the protocol requirements
- Patients with a proven infectious disease (e.g. SARS-COV-19, MRSA) that requires isolation of the patient
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Kinder- und Jugendmedizin Klinikum Traunstein
Traunstein, 83278
About this study
Official title: Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500) to Monitor Changes in Lung Ventilation Over Time in Mechanically Ventilated Children.
This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients.
The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle.
PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the capability of PulmoVista 500 for continuous monitoring of ventilation
To assess the capability of PulmoVista 500 for continuous monitoring of ventilation, the cross-correlation function (CCF) between the global impedance waveform of EIT and global tidal volume waveforms of a ventilator across multiple respiratory cycles in patients under controlled mechanical ventilation, will be evaluated.
Measured: Duration per participant: 2 - 3 days (screening, procedure with PulmoVista 500, safety follow-up). Measurements with PulmoVista 500 per patient during mechanical ventilation is anticipated for a maximum of 10 minutes in total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start3 May 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
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 Monitoring of Regional Distribution of 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drägerwerk AG & Co. KGaA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerhard Wolf, PD Dr., Principal investigator, Children's hospital Traunstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873999
- Sponsor's protocol ID
- PV500ped
- Acronym
- PV500ped
- Status last verified
- Mar 2022
- First submitted
- 30 Apr 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
PubMed 37046213
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500) to Monitor Changes in Lung Ventilation Over Time in Mechanically Ventilated Children.
- ClinicalTrials.gov ID
- NCT04873999
- Acronym / sponsor ID
- PV500ped / PV500ped
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Drägerwerk AG & Co. KGaAIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 5 May 2021 (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.
This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients.
The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle.
PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients that visit the hospital for any kind of surgery, therefore requireing mechanical ventilation. Monitoring of Regional Distribution of Ventilation and Lung Volume are of clinical interest in these patients.
Key inclusion criteria (8 listed)
- Pediatric male or female patients excluding preterm infants
- Patients with a chest circumference between 36 and 72 cm
- Patients ≤ 12 years.
- Patients with a tidal volume > 20 ml, i.e., children with a body weight of more than 3.3 kg (assuming a targeted tidal volume of 6 mL/kg body weight)
- Patients for whom mechanical ventilation is intended
Key exclusion criteria (8 listed)
- Patients who are supplied with a permanent or temporary pacemaker, an implantable defibrillator or other medical devices that emit electrical energy (e.g. cochlea amplifier implant)
- Patients with a tidal volume ≤ 20 ml
- Patients in whom the application of the electrode belt could be impaired by wound care or infections in the chest area
- Female patients for whom pregnancy cannot be excluded; a pregnancy test should be performed at the discretion of the investigator.
- Patients with an alleged allergic reaction to the materials of the electrode belt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess the capability of PulmoVista 500 for continuous monitoring of ventilation
Time frame: Duration per participant: 2 - 3 days (screening, procedure with PulmoVista 500, safety follow-up). Measurements with PulmoVista 500 per patient during mechanical ventilation is anticipated for a maximum of 10 minutes in total.
To assess the capability of PulmoVista 500 for continuous monitoring of ventilation, the cross-correlation function (CCF) between the global impedance waveform of EIT and global tidal volume waveforms of a ventilator across multiple respiratory cycles in patients under controlled mechanical ventilation, will be evaluated.
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 29 Mar 2022.
- Derived from this study: PubMed 37046213Clasen D, Winter I, Rietzler S, Wolf GK. Changes in ventilation distribution during general anesthesia measured with EIT in mechanically ventilated small children. BMC Anesthesiol. 2023 Apr 12;23(1):118. doi: 10.1186/s12871-023-02079-z.
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.
Gerhard Wolf, PD Dr. principal investigator
Children's hospital Traunstein
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 Monitoring of Regional Distribution of Ventilation and Monitoring of Lung Volume, 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 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 29 Mar 2022. 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?
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?
assess the capability of PulmoVista 500 for continuous monitoring of ventilation (time frame: Duration per participant: 2 - 3 days (screening, procedure with PulmoVista 500, safety follow-up). Measurements with PulmoVista 500 per patient during mechanical ventilation is anticipated for a maximum of 10 minutes in total.). 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 NCT04873999, 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 29 Mar 2022.