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

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 Overview

• Status: Completed
• Conditions: ARDS; Mechanical Ventilation; Single-lung Ventilation; ALI - Acute Lung Injury; Weaning From Ventilator
• Intervention / Treatment: Device: Lung Monitoring with EIT device (PulmoVista 500)

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Bremerhaven, Germany, 27574
    • Klinikum Bremerhaven-Reinkenheide gGmbH
  • Dresden, Germany, 01307
    • Universitatsklinik Dresden
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover (MHH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria

- 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
• 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.

Exclusion Criteria

• 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.
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU Patients; Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)	Device: 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.
OLV Patients; Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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"	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	Day 1
Safety - Documentation of Any Safety Events	Documentation of any safety events related to the use of PulmoVista 500	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?"	Day 1

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Collaborators: KKS Dresden
• Investigators: Principal Investigator: Peter M Spieth, Prof.Dr. med., Universitätsklinikum Dresden; Study Chair: Oliver C Radke, Prof. Dr., Klinikum Bremerhaven-Reinkenheide gGmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography; Ventilation Monitoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: PV500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No