Primary Objective: To study the options of the PulmoVista 500 system to visualize regional real-time lung ventilation in healthy volunteersResearch questions:- Can the PulmoVista 500 system provide sufficient information regarding regional lung…
ID
Source
Brief title
Condition
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The main endpoint of this study is to gain insight in the possibilities of
the PulmoVista system to visualize lung ventilation in healthy subjects aged
18-65.
2) Another main endpoint is the effect of different positions on lung
ventilation. To this end, healthy subject will be placed in different positions
(specified below) and regional ventilation will be assessed using the
PulmoVista system
3) The effect of applying CPAP for a short time period will be tested on
healthy subjects.
Secondary outcome
1) The number of adverse and serious adverse events will be documented,
although it is not expected to occur in this study.
2) Experience of operators working with this technique.
This will be qualitative data and the data will be used to correctly interpret
data and to set-up studies in the future.
Background summary
Rib fractures are common in patients with thoracic trauma and might lead to the
necessity of mechanical ventilation due to respiratory insufficiency. This type
of ventilation can however lead to increased lung damage, making closely
monitored ventilator device settings essential. These settings are presently
based on global lung parameters, which cannot provide detailed information on
regional lung ventilation and it can therefore be expected that treatment is
not optimal. Current imaging methods for lung ventilation have numerous
disadvantages, which increases the need for a technique that can account for
these disadvantages. Electrical impedance tomography is a noninvasive technique
that provides real-time cross-sectional ventilation images of the lung at the
bedside. Literature and experience regarding the use of EIT is scarce. The aim
of this study is to assess the possibility of the PulmoVista system in
visualizing real-time regional lung ventilation in healthy subjects, wherein
this group the effect of different positions and the application of CPAP will
be assessed as well.
Hypothesis: We hypothesize that EIT can provide valuable information regarding
regional ventilation in healthy subjects. We expect that different positions
influences regional ventilation and that this can be visualized by using the
EIT technique. In addition we hypothesize that applying a small amount of CPAP
leads to increased regional ventilation as visualized by the PulmoVista 500
system.
Study objective
Primary Objective:
To study the options of the PulmoVista 500 system to visualize regional
real-time lung ventilation in healthy volunteers
Research questions:
- Can the PulmoVista 500 system provide sufficient information regarding
regional lung ventilation in both a graphical and numerical way?
- How do different positions of a healthy subject influence (regional) lung
ventilation?
- What is the effect of applying CPAP for a short time period in healthy
subjects on (regional) lung ventilation?
There is no gold standard for visualizing regional lung ventilation. Currently,
the best way of visualizing lung ventilation is dynamic Computer Tomography
(CT-scan). When PulmoVista proves to be a good way for visualizing lung
ventilation this might become the gold standard.
Secondary Objective(s):
To study the operators* experiences and opinions in using the system regarding
efficiency, usefulness, ease of use and time needed to prepare for the
measurements. Practical issues and difficulties in interpreting the data will
also be documented.
Information regarding this topic will provide the investigators with an
overview on the utilization of the technology. It will be used by the
investigators of this study to correctly interpret gathered data and it will be
used to set up studies that will be conducted in the future, i.e. with respect
to overcome or cope with difficulties in using the technique resulting from
this study.
Study design
Prospective obervational non-invasive study with a duration of two months
For all subjects, a belt containing electrodes is placed on 4th-6th intercostal
area of the healty subjects chest while the healthy subject lies in a 30º
angle. It is important that subjects lie still during the measurement time as
the signal can be contaminated with noise caused by movement.
Healthy volunteers
2a. With and without CPAP: A CPAP level of 5 cm H2O will be applied during 6
minutes after two minutes of normal breathing.
2b. Influence of different angles. The subject lies during 8 minutes in: ,0º,
30º, 45º, Prone position.
Data collection:
Parameters that will be used in this study are:
- Gender
- Age
- BMI
- End-expiratory lung volume
- Tidal volume
- FiO2
- PaO2/FiO2 ratio (kPa)
- Dynamic compliance (ml/cmH2O)
- Functional EIT image (*fEIT)
Study burden and risks
The risk of specific complications during participation is low. The regional
ventilation monitoring provided by PulmoVista 500 is non-invasive and without
any side-effects. No ionizing radiation is involved. EIT involves minimal
preparation so monitoring is established in just a few minutes. Preparation
only requires the positioning of a flexible non-adhesive belt around the healty
subjects chest. Long-term measurements could lead to skin irritation, the
manufacturer therefore advises not to exceed 24 hours of measuring. It is
expected that measurements in this study will take 40 minutes, including
preparation and termination. This period of time lies beneath 24 hours, so the
risk of occurrence of skin irritations is low.
P. Debyelaan 25
AZ 6202
NL
P. Debyelaan 25
AZ 6202
NL
Listed location countries
Age
Inclusion criteria
Group 1 (healthy subjects):
1. Age 18-65 years
2. BMI 18.4 * 24.9 kg/m2
3. Gender: both male and female
Exclusion criteria
Group 1 (healthy subjects):
1. Conditions that interfere with respiration e.g.
- asthma
- COPD
- hyperventilation
- Previous claustrophobic conditions
- Recent (<6 months) thoracal trauma
- Recent (<6 months) lungdisease, thorax disease
- Previous allergic reaction on mask ventilation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52043.068.15 |