Trial Outcomes & Findings for Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time (NCT NCT03076983)

Last Updated: 2019-11-27

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

Day 1

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	ICU Patients Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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) 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.
Overall Study STARTED	55	25
Overall Study COMPLETED	55	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICU Patients n=55 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 Participants Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.	Total n=80 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 13.8 • n=93 Participants	59.1 years STANDARD_DEVIATION 12.5 • n=4 Participants	60.4 years STANDARD_DEVIATION 13.4 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	10 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	15 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	55 Participants n=93 Participants	25 Participants n=4 Participants	80 Participants n=27 Participants
Region of Enrollment Germany	55 participants n=93 Participants	25 participants n=4 Participants	80 participants n=27 Participants
Height	172.02 Centimetre STANDARD_DEVIATION 9.29 • n=93 Participants	170.96 Centimetre STANDARD_DEVIATION 10.69 • n=4 Participants	171.69 Centimetre STANDARD_DEVIATION 9.70 • n=27 Participants
Weight	79.75 kilogram STANDARD_DEVIATION 21.25 • n=93 Participants	80.84 kilogram STANDARD_DEVIATION 15.68 • n=4 Participants	80.09 kilogram STANDARD_DEVIATION 19.59 • n=27 Participants
Body mass index	26.87 kg/m^2 STANDARD_DEVIATION 6.33 • n=93 Participants	27.62 kg/m^2 STANDARD_DEVIATION 4.89 • n=4 Participants	27.11 kg/m^2 STANDARD_DEVIATION 5.90 • n=27 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	ICU Patients n=54 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 Participants Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
Monitoring Capabilities of PulmoVista 500	0.9692 correlation coefficient Standard Deviation 0.0627	0.9093 correlation coefficient Standard Deviation 0.1351

SECONDARY outcome

Timeframe: Day 1

Population: For this secondary endpoint the cross-correlation between between impedance waveforms derived from PulmoVista 500 and volume curves derived from Ventilator was calculated only for patients which received one-lung-ventilation (OLV). Therefore no patients from the ICU patients Group were included into the analysis.

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.

Outcome measures

Outcome measures
Measure	ICU Patients Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 Participants Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
Detection of Changes in Regional Ventilation	—	0.9093 correlation coefficient Standard Deviation 0.1351

SECONDARY outcome

Timeframe: Day 1

Population: This question is only applicable to the patient group of "ICU Patients" as no assessment of the changes of tidal volumes induced by ventilator settings was planned a priori for the "OLV" patient group.

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"

Outcome measures

Outcome measures
Measure	ICU Patients n=55 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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) 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.
Assess Changes of Tidal Volumes Answer:No	3 Participants	—
Assess Changes of Tidal Volumes Answer: Yes	49 Participants	—
Assess Changes of Tidal Volumes Answer: N/A	3 Participants	—

SECONDARY outcome

Timeframe: Day 1

Population: These two questions are only applicable to the patient group of "ICU Patients" as no assessment of the changes of the end-expiratory lung volume was planned a priori within the "OLV" patient group.

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

Outcome measures

Outcome measures
Measure	ICU Patients n=55 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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) 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.
Assess Changes of the End-expiratory Lung Volumes Question 1 · Answer: "No"	1 Participants	—
Assess Changes of the End-expiratory Lung Volumes Question 1 · Answer: "Yes"	51 Participants	—
Assess Changes of the End-expiratory Lung Volumes Question 1 · Answer: "N/A	3 Participants	—
Assess Changes of the End-expiratory Lung Volumes Question 2 · Answer: "No"	0 Participants	—
Assess Changes of the End-expiratory Lung Volumes Question 2 · Answer: "Yes"	29 Participants	—
Assess Changes of the End-expiratory Lung Volumes Question 2 · Answer: "N/A	26 Participants	—

SECONDARY outcome

Timeframe: Day 1

Documentation of any safety events related to the use of PulmoVista 500

Outcome measures

Outcome measures
Measure	ICU Patients n=55 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 Participants Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
Safety - Documentation of Any Safety Events Subjects with any AE · no	43 Participants	13 Participants
Safety - Documentation of Any Safety Events Subjects with any AE · yes	12 Participants	12 Participants
Safety - Documentation of Any Safety Events Subjects with any ADE · no	55 Participants	25 Participants
Safety - Documentation of Any Safety Events Subjects with any ADE · yes	0 Participants	0 Participants
Safety - Documentation of Any Safety Events Subjects with any SAE · no	48 Participants	24 Participants
Safety - Documentation of Any Safety Events Subjects with any SAE · yes	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Outcome measures
Measure	ICU Patients n=55 Participants Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 Participants Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
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" Question 6 · 3	9 Participants	10 Participants
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" Question 7 · 2	0 Participants	1 Participants
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" Question 9 · 3	10 Participants	14 Participants
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" Question 9 · 4	10 Participants	6 Participants
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" Question 2 · 4	3 Participants	3 Participants
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" Question 1 · 1 = very difficult / not useful at all	0 Participants	0 Participants
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" Question 1 · 2	0 Participants	0 Participants
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" Question 1 · 3	2 Participants	0 Participants
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" Question 1 · 4	1 Participants	0 Participants
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" Question 1 · 5 = very easy / very useful	52 Participants	25 Participants
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" Question 2 · 1 = very difficult / not useful at all	0 Participants	0 Participants
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" Question 2 · 2	0 Participants	0 Participants
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" Question 2 · 3	2 Participants	0 Participants
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" Question 2 · 5 = very easy / very useful	50 Participants	22 Participants
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" Question 3 · 1 = very difficult / not useful at all	0 Participants	0 Participants
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" Question 3 · 2	0 Participants	0 Participants
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" Question 3 · 3	0 Participants	2 Participants
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" Question 3 · 4	0 Participants	2 Participants
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" Question 3 · 5 = very easy / very useful	55 Participants	21 Participants
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" Question 4 · 1 = very difficult / not useful at all	0 Participants	1 Participants
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" Question 4 · 2	0 Participants	1 Participants
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" Question 4 · 3	2 Participants	0 Participants
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" Question 4 · 4	2 Participants	3 Participants
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" Question 4 · 5 = very easy / very useful	51 Participants	20 Participants
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" Question 5 · 1 = very difficult / not useful at all	0 Participants	1 Participants
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" Question 5 · 2	0 Participants	1 Participants
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" Question 5 · 3	0 Participants	2 Participants
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" Question 5 · 4	2 Participants	9 Participants
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" Question 5 · 5 = very easy / very useful	53 Participants	12 Participants
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" Question 6 · 1 = very difficult / not useful at all	0 Participants	1 Participants
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" Question 6 · 2	0 Participants	1 Participants
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" Question 6 · 4	11 Participants	11 Participants
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" Question 6 · 5 = very easy / very useful	35 Participants	2 Participants
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" Question 7 · 1 = very difficult / not useful at all	0 Participants	0 Participants
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" Question 7 · 3	0 Participants	2 Participants
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" Question 7 · 4	0 Participants	5 Participants
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" Question 7 · 5 = very easy / very useful	55 Participants	17 Participants
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" Question 8 · 1 = very difficult / not useful at all	0 Participants	1 Participants
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" Question 8 · 2	0 Participants	2 Participants
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" Question 8 · 3	2 Participants	1 Participants
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" Question 8 · 4	3 Participants	5 Participants
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" Question 8 · 5 = very easy / very useful	50 Participants	16 Participants
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" Question 9 · 1 = very difficult / not useful at all	0 Participants	2 Participants
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" Question 9 · 2	0 Participants	2 Participants
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" Question 9 · 5 = very easy / very useful	35 Participants	1 Participants

Adverse Events

ICU Patients

Serious events: 7 serious events

Other events: 2 other events

Deaths: 0 deaths

OLV Patients

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ICU Patients n=55 participants at risk Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 participants at risk Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
Injury, poisoning and procedural complications Post procedural swelling	3.6% 2/55 • Number of events 2 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Injury, poisoning and procedural complications Vascular graft complication	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.6% 2/55 • Number of events 2 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Cardiac disorders Cardiogenic shock	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Vascular disorders Haemodynamic instability	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Nervous system disorders Intracranial pressure increased	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	0.00% 0/25 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Cardiac disorders Cardiac arrest	0.00% 0/55 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	4.0% 1/25 • Number of events 1 • 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

Other adverse events
Measure	ICU Patients n=55 participants at risk Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU) 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 n=25 participants at risk Patients scheduled for elective surgery receiving one-lung-ventilation (OLV) 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.
Injury, poisoning and procedural complications Procedural pain	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	48.0% 12/25 • Number of events 12 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Psychiatric disorders Delirium	1.8% 1/55 • Number of events 1 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	8.0% 2/25 • Number of events 2 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.
Vascular disorders Hypotension	0.00% 0/55 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.	8.0% 2/25 • Number of events 2 • Adverse Event data were collected during the follow-up visit, which takes place once within 1-3 days period after the study day.

Additional Information

Mr. Robin Hüwel

Drägerwerk AG & Co. KGaA

Phone: +49 451 882 6830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60