Primary objectiveTo detect the difference in mean arterial blood pressure between conventional APRV settings and APRV settings based on EIT measurements, in patients with ARDS.Secondary objectivesImproved dorsal ventilation distribution on EIT…
ID
Source
Brief title
Condition
- Pleural disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean arterial blood pressure
Secondary outcome
Homogeneous ventilation (intratidal gas distribution) of the lungs as measured
by EIT
Blood gas exchange
Respiratory parameters
Cardiac Output (if available)
Background summary
Airway pressure release ventilation (APRV) uses relative 'high' continuous
inspiratory pressure at which spontaneous breathing can take place in
combination with an ultra-short expiration time in order to exhale. APRV has
been used for the respiratory management in the patients with ARDS and showed
improved gas exchange with less sedation. However, it remains unclear how to
estimate the optimal level of the inspiratory pressure (Phigh) during APRV in
patients with severe ARDS. The hemodynamic instability due to reduced cardiac
output may occur when this pressure is set too high. Therefore, in this study
we would like to evaluate if Electrical Impedance Tomography (EIT) can be used
to optimize this high pressure level leading to less compromise of the
hemodynamics as compared to the current standard.
Study objective
Primary objective
To detect the difference in mean arterial blood pressure between conventional
APRV settings and APRV settings based on EIT measurements, in patients with
ARDS.
Secondary objectives
Improved dorsal ventilation distribution on EIT image
Improved arterial oxygenation
Improved minute ventilation
Normocapnea
Improved comfort level (RASS score)
Reduced amounts of sedation
Cardiac Output (if available)
Study design
The study is designed as a cross-over intervention study. Patients with severe
ARDS will be enrolled. Baseline EIT measurement will be performed during
conventional controlled ventilation (CMV). Thereafter, the ventilatory mode
will be switched from CMV to APRV mode at 2 different Phigh levels. The
sequence of the pressure levels will be randomized by using the closed envelope
method. After a steady state of 20 minutes, EIT, hemodynamic and respiratory
parameters, blood gases will be measured.
Intervention
After baseline measurement, ventilator mode is switched from CMV to APRV.
Phigh levels are determined based on EIT measurements.
The order of both APRV settings will be randomized.
Study burden and risks
In this study the influence of high pressure levels on hemodynamics and
ventilation distribution during APRV will be studied in the patients with
severe ARDS. The levels of high pressure, identical to peak airway pressures,
will be kept below 32 cm H2O according to our clinical protocol. In addition,
the EIT measurements and surface EMG of the diaphragm will be performed
non-invasively and for blood gas analyses a maximum of 10 mL extra blood for
the entire study will be collected during this study.
If we are able to improve the APRV settings by the use of EIT measurements, the
time on the ventilator might be reduced.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
>18 years
Written informed consent from legal representatives
PaO2/FiO2 ratio <100 : severe ARDS
Exclusion criteria
<18 years
Hemodynamically unstable
Thorax drainage
Open thoracic wounds
Design
Recruitment
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 | NL46954.078.13 |