N/A
Completed N=80
Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
Mechanical Ventilation · Single-lung Ventilation · Acute Respiratory Distress Syndrome · ALI - Acute Lung Injury
Source: ClinicalTrials.gov NCT03076983 ↗
Enrolled (actual)
80
Serious AEs
10.0%
Results posted
Oct 2019
Primary outcomePrimary: Monitoring Capabilities of PulmoVista 500 — 0.9692; 0.9093 correlation coefficient
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monitoring Capabilities of PulmoVista 500 |
0.9692; 0.9093 | — |
| SECONDARY Detection of Changes in Regional Ventilation |
0.9093 | — |
| SECONDARY Assess Changes of Tidal Volumes |
3; 49; 3 | — |
| SECONDARY Assess Changes of the End-expiratory Lung Volumes |
1; 51; 3; 0; 29; 26 | — |
| SECONDARY Safety - Documentation of Any Safety Events |
43; 13; 12; 12; 55; 25 | — |
| SECONDARY 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" |
0; 0; 0; 0; 2; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03076983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.