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

Completed

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

• Registration Number: NCT03076983
• Lead Sponsor: Drägerwerk AG & Co. KGaA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Study Start: 2017-05-30
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Results First Submitted: 2019-07-18
• Results First Submitted QC: 2019-09-25
• Results First Posted: 2019-10-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OLV Patients	Lung Monitoring with EIT device (PulmoVista 500)	Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)
ICU Patients	Lung Monitoring with EIT device (PulmoVista 500)	Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)

Primary Outcome Measures

Name	Time	Method
Monitoring Capabilities of PulmoVista 500	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)

Secondary Outcome Measures

Name	Time	Method
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"	Day 1	"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?"
Detection of Changes in Regional Ventilation	Day 1	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.
Assess Changes of Tidal Volumes	Day 1	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"
Safety - Documentation of Any Safety Events	Day 1	Documentation of any safety events related to the use of PulmoVista 500
Assess Changes of the End-expiratory Lung Volumes	Day 1	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

Trial Locations

Locations (3)

Klinikum Bremerhaven-Reinkenheide gGmbH; 🇩🇪 Bremerhaven, Germany

Medizinische Hochschule Hannover (MHH); 🇩🇪 Hannover, Germany

Universitätsklinik Dresden; 🇩🇪 Dresden, Germany