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

NCT03076983 | Completed Results DMC

• 1 other identifier: PV500
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Mechanical Ventilation; Single-lung Ventilation; ARDS; ALI - Acute Lung Injury; Weaning From Ventilator

Keywords

Ventilation Monitoring; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Detection of Changes in Regional Ventilation

  Day 1

• Assess Changes of Tidal Volumes

  Day 1

• Assess Changes of the End-expiratory Lung Volumes

  Day 1

• Safety - Documentation of Any Safety Events

  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"

  Day 1

Study Arms (2)

ICU Patients

Patients currently on or scheduled for ventilator care in the intensive-care-unit (ICU)

Device: Lung Monitoring with EIT device (PulmoVista 500)

OLV Patients

Patients scheduled for elective surgery receiving one-lung-ventilation (OLV)

Device: Lung Monitoring with EIT device (PulmoVista 500)

Interventions

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.

ICU Patients; OLV Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Drägerwerk AG & Co. KGaA: lead
• Technische Universität Dresden: collaborator

Study Sites (3)

Klinikum Bremerhaven-Reinkenheide gGmbH

Bremerhaven, 27574, Germany

Location

Universitätsklinik Dresden

Dresden, 01307, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mr. Robin Hüwel
• Organization: Drägerwerk AG & Co. KGaA

ClinicalAffairs@draeger.com

+49 451 882 6830

Study Officials

• Peter M Spieth, Prof.Dr. med.

  Universitätsklinikum Dresden

  PRINCIPAL INVESTIGATOR

• Oliver C Radke, Prof. Dr.

  Klinikum Bremerhaven-Reinkenheide gGmbH

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 10, 2017
• Study Start: May 30, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: November 27, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)