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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-30

Study Completion Date

2018-04-12

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU Patients

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

Lung Monitoring with EIT device (PulmoVista 500)

Intervention Type 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.

OLV Patients

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

Lung Monitoring with EIT device (PulmoVista 500)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No