N/A
N=80
Assessment of the Capability of PulmoVista 500 to Continuously Monitor Changes of Ventilation Over Time
Mechanical Ventilation · Single-lung Ventilation · ARDS · ALI - Acute Lung Injury · Weaning From Ventilator
Bottom Line
View on ClinicalTrials.gov: NCT03076983 ↗Enrolled (actual)
80
Serious AEs
10.0%
Results posted
Oct 2019
Primary outcome: Primary: Monitoring Capabilities of PulmoVista 500 — 0.9692; 0.9093 correlation coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lung Monitoring with EIT device (PulmoVista 500) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Drägerwerk AG & Co. KGaA
- Primary completion
- Apr 2018
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 | — |
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.
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.