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

Launched by DRÄGERWERK AG & CO. KGAA · Mar 9, 2017

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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