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

Dräger

Status

Completed

Conditions

ALI - Acute Lung Injury

Mechanical Ventilation

ARDS

Weaning From Ventilator

Single-lung Ventilation

Treatments

Device: Lung Monitoring with EIT device (PulmoVista 500)

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT03076983

PV500

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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