Mechanical VentilationNCT03076983

Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time

An observational study of Mechanical Ventilation and Single-lung Ventilation, run by Drägerwerk AG & Co. KGaA at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mechanical Ventilation, Single-lung Ventilation, ARDS
What is being tested?: Lung Monitoring with EIT device (PulmoVista 500)
Type of treatment: Medical device
How many people: 80 participants
Where: 3 sitesGermany
Study dates: 30 May 2017to 12 Apr 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Intensive care unit (ICU) patients, who are mechanically ventilated via an artificial airway (endotracheal tube or tracheostomy cannula) and who are expected to be subjected to major changes in their ventilator settings will be monitored with the PulmoVista 500 device before, during and after the changes. These changes in the ventilator settings should result in recognizable changes in the distribution of ventilation in the lungs. AND Patients who are scheduled for surgeries that require blocking of one bronchus

Who may be able to join

The population included in the clinical study will be selected from a pool of patients undergoing respiratory support who are scheduled to have their ventilation settings changed.
As a subgroup, patients who are scheduled for surgeries that need one-lung-ventilation (OLV) will be enrolled to the study.
Male and female patients at the age of 18 years or older
On respiratory support in ICU care or scheduled for such ( e.g. postoperatively) or scheduled for surgery with OLV
Patients of which the monitoring of ventilation distribution may be of clinical interest
Patients being ventilated via an artificial airway with a mechanical ventilator that is compatible with PulmoVista 500

Show all 9Show fewer

Patients scheduled for changes in ventilation settings that may cause relevant changes in the ventilation
Chest circumference between 70 and 150 cm
Written informed consent to participate in the study provided by either the patient or the legal representative of the patient.

Who cannot join

Currently has a permanent or temporary pacemaker, implantable cardiac device (ICD) or other device emitting electrical energy
a BMI ≥ 50
tidal volume (VT) ≤ 200 mL
Current uncontrolled body movements such as tics, tremors or seizures,
Current wound dressings or infections on the chest that might interfere with the PulmoVista 500 electrode belt placement
Women of child bearing potential whose pregnancy cannot be excluded based on a pregnancy test or other proven facts.

Show all 11Show fewer

Allergic to materials used in the electrode belt
Participation of the patient in an interventional trial within the last four weeks before enrollment in this trial
Evidence suggesting that the patient or his legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
Known infectious diseases that require isolation of patient (e.g. MRSA)
Concomitant use of an air anti-decubitus medical mattress with dynamic inflation that cannot be deactivated during EIT measurements

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

Klinikum Bremerhaven-Reinkenheide gGmbH
Bremerhaven, 27574
Universitätsklinik Dresden
Dresden, 01307
Medizinische Hochschule Hannover (MHH)
Hanover, 30625

Other trials in Germany

About this study

The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation.

Conditions: Mechanical Ventilation, Single-lung Ventilation, ARDS, ALI - Acute Lung Injury, Weaning From Ventilator
Being tested: Lung Monitoring with EIT device (PulmoVista 500)
Keywords: Ventilation Monitoring, Electrical Impedance Tomography
Medical subject headings: Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lung Monitoring with EIT device (PulmoVista 500)Device
Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).
No medical interventions to routine patient care required.

Study groups in NCT03076983
Study group	Role	What they receive
ICU Patients		Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) Receives: Device: Lung Monitoring with EIT device (PulmoVista 500)
OLV Patients		Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) Receives: Device: Lung Monitoring with EIT device (PulmoVista 500)

What is being measured

The primary outcome is the main question the study is designed to answer.

Monitoring Capabilities of PulmoVista 500
The cross-correlation between the volume curve of the ventilator and the global impedance curve of PulmoVista 500 was expressed by the cross-correlation coefficient R.
The cross-correlation coefficient is a measure to quantify the relationship between the volume curve and the EIT curve.
The correlation coefficient R can assume values between [-1, 1] to describe the relationship between the two curves, as is usual for a correlation.
To calculate the correlation coefficient, a phase shift between the two curves was taken into account, so the cross-correlation between them was calculated.
The phase shift or delay occurs when the signal from the fan is transmitted to the PulmoVista500.
The cross-correlation coefficient is determined by calculating the correlation coefficient for the curves within a narrow range of Lags(-15 to 15 ) for each pair of curves and using the maximum value as the value of correlation coefficient (therefore it is called cross-correlation coefficient)
Measured: Day 1

Secondary outcomes (5)

Detection of Changes in Regional Ventilation
To assess the capability of PulmoVista 500 to detect changes in regional ventilation by evaluating the cross correlation between impedance waveforms derived from PulmoVista 500 and volume curves derived from ventilator during one-lung-ventilation.
Measured: Day 1
Assess Changes of Tidal Volumes
Assess that changes of tidal volumes induced by ventilator settings can be monitored by the "Trends view"
To assess if the changes of tidal volumes induced by ventilator settings can be monitored by the "Trends view", the physician was asked to answer following question of a questionnaire:
"Open the view "End-insp. trend" after the PEEP setting has been changed significantly (2 mbar or more). Set C1 at the lower and C2 at the higher PEEP level.
Does the image Change: C2 minus C1 and/or the corresponding regional Tidal Variations show the expected redistribution of ventilation from ventral to dorsal?"
Possible answers were: "No", "Yes" and "N/A"
Measured: Day 1
Assess Changes of the End-expiratory Lung Volumes
Assess that changes of the end-expiratory lung volumes (induced by e.g. PEEP changes, recruitment and suctioning maneuvers) can be monitored by "dEELI trend view"
To assess if the changes of the end-expiratory lung volumes (induced by e.g. PEEP changes, recruitment and suctioning maneuvers) can be monitored by "dEELI trend view", the physician was asked to answer following two question of a questionnaire:
Question 1: "Open the view "dEELI trend" after the PEEP setting has been changed. Set C1 at the lower and C2 at the higher PEEP level. Does the image dEELI: C2 minus C1 show the expected increase of end-exp. lung volume in turquoise (light-blue)?"
Question 2: "Open the view "dEELI trend" after lung suction has been conducted. Set C1 at a phase before and C2 during or immediately after the lung suction. Does the image dEELI: C2 minus C1 show the expected decrease of lung volume in orange color?"
Possible answers for the both above mentioned questions were "No","Yes" or "N/A2
Measured: Day 1
Safety - Documentation of Any Safety Events
Documentation of any safety events related to the use of PulmoVista 500
Measured: Day 1
Assessing the Use Specific Clinical Helpfulness of PulmoVista 500 by Particular Questionnaire. The Questions Which Were Asked Within the Questionaire Are Listed in the "Outcome Measure Description"
"How easy is it to...
Q1: ... identify within the Tidal Image, whether the right and the left lung are evenly ventilated?" Q2: ... quantify the regional ventilation distribution as expressed by the regional Parameters TV ROI 1 - TV ROI 4?" Q3: ... set the cursors to respective positions which allow you to compare ventilation distribution before and after the intervention?" Q4: ... detect increases and/or decreases of regional ventilation?" Q5: ... relate the regional ventilation distribution to and the corresponding parameters from the ventilator, which are displayed in the trend table to each other?" Q7: ... set the cursors to respective positions which allows you assessing lung volume changes induced by the intervention?" Q8: ... detect increases and/or decreases of regional lung volume?"
"How useful is the clinical Information on...
Q6: ... ventilation redistribution caused by this intervention?" Q9: ... regional lung volume changes caused by this intervention?"
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201712 Apr 2018

First posted10 Mar 2017
Study start30 May 2017
Primary completion12 Apr 2018
Study completion12 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03076983
Sponsor's protocol ID: PV500
Status last verified: Nov 2019
First submitted: 22 Feb 2017
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mechanical Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
ClinicalTrials.gov ID: NCT03076983
Acronym / sponsor ID: PV500
Conditions: Mechanical Ventilation, Single-lung Ventilation, ARDS, ALI - Acute Lung Injury, Weaning From Ventilator
Keywords: Ventilation Monitoring, Electrical Impedance Tomography
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Drägerwerk AG & Co. KGaAIndustry (pharma, biotech, devices)
Collaborators: Technische Universität Dresden
Study start: 30 May 2017 (actual)
Primary completion: 12 Apr 2018 (actual)
Study completion: 12 Apr 2018 (actual)
First posted: 10 Mar 2017 (actual)
Results: Posted 18 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The results of this study will help to define the capability and reliability of PulmoVista 500 to detect changes in both global and regional ventilation.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
ICU Patients	–	Device: Lung Monitoring with EIT device (PulmoVista 500)Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)
OLV Patients	–	Device: Lung Monitoring with EIT device (PulmoVista 500)Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Intensive care unit (ICU) patients, who are mechanically ventilated via an artificial airway (endotracheal tube or tracheostomy cannula) and who are expected to be subjected to major changes in their ventilator settings will be monitored with the PulmoVista 500 device before, during and after the changes. These changes in the ventilator settings should result in recognizable changes in the distribution of ventilation in the lungs. AND Patients who are scheduled for surgeries that require blocking of one bronchus

Key inclusion criteria (9 listed)

The population included in the clinical study will be selected from a pool of patients undergoing respiratory support who are scheduled to have their ventilation settings changed.
As a subgroup, patients who are scheduled for surgeries that need one-lung-ventilation (OLV) will be enrolled to the study.
Male and female patients at the age of 18 years or older
On respiratory support in ICU care or scheduled for such ( e.g. postoperatively) or scheduled for surgery with OLV
Patients of which the monitoring of ventilation distribution may be of clinical interest

Key exclusion criteria (11 listed)

Currently has a permanent or temporary pacemaker, implantable cardiac device (ICD) or other device emitting electrical energy
a BMI ≥ 50
tidal volume (VT) ≤ 200 mL
Current uncontrolled body movements such as tics, tremors or seizures,
Current wound dressings or infections on the chest that might interfere with the PulmoVista 500 electrode belt placement

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
Lung Monitoring with EIT device (PulmoVista 500)Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500). No medical interventions to routine patient care required.	Device	ICU Patients, OLV Patients

Primary outcome

Monitoring Capabilities of PulmoVista 500
Time frame: Day 1
The cross-correlation between the volume curve of the ventilator and the global impedance curve of PulmoVista 500 was expressed by the cross-correlation coefficient R. The cross-correlation coefficient is a measure to quantify the relationship between the volume curve and the EIT curve. The correlation coefficient R can assume values between [-1, 1] to describe the relationship between the two curves, as is usual for a correlation. To calculate the correlation coefficient, a phase shift between the two curves was taken into account, so the cross-correlation between them was calculated. The phase shift or delay occurs when the signal from the fan is transmitted to the PulmoVista500. The cross-correlation coefficient is determined by calculating the correlation coefficient for the curves within a narrow range of Lags(-15 to 15 ) for each pair of curves and using the maximum value as the value of correlation coefficient (therefore it is called cross-correlation coefficient)

5 secondary outcomes

Detection of Changes in Regional Ventilation
Time frame: Day 1
Assess Changes of Tidal Volumes
Time frame: Day 1
Assess Changes of the End-expiratory Lung Volumes
Time frame: Day 1
Safety - Documentation of Any Safety Events
Time frame: Day 1
Assessing the Use Specific Clinical Helpfulness of PulmoVista 500 by Particular Questionnaire. The Questions Which Were Asked Within the Questionaire Are Listed in the "Outcome Measure Description"
Time frame: Day 1

Results and safety

Results posted to the registry on 18 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICU Patients	55	55
OLV Patients	25	25

Primary outcome: Monitoring Capabilities of PulmoVista 500

Time frame: Day 1. Mean (Standard Deviation). Unit: correlation coefficient

Measure	ICU Patients n = 54	OLV Patients n = 25
Value	0.9692 (0.0627)	0.9093 (0.1351)

Population analysed: A Intention-to-Treat (ITT) collective was used as analysis population. The intention-to-treat collective comprises all patients for which both, the impedance waveforms and parallel to them volume waveforms have been generated during ventilation,so that the primary endpoint can be evaluated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICU Patients	7 of 55 (12.7%)	2 of 55 (3.6%)	0 of 55
OLV Patients	1 of 25 (4%)	12 of 25 (48%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Mechanical Ventilation

Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
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DIAPHRAGM STRENGTH AND LUNG VOLUMES
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Recruiting
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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.

Peter M Spieth, Prof.Dr. med. principal investigator

Universitätsklinikum Dresden

Oliver C Radke, Prof. Dr. study chair

Klinikum Bremerhaven-Reinkenheide gGmbH

3 sites 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 Single-lung Ventilation, run by Drägerwerk AG & Co. KGaA at 3 sites 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 9 inclusion and 11 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Monitoring Capabilities of PulmoVista 500 (time frame: Day 1). 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 NCT03076983.

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 27 Nov 2019.