The primary objective of this study is to investigate the relation between, on the one hand, 1) the balance between the respiratory system mechanics and muscle dynamics, and 2) the balance between the pressure support level and respiratory drive,…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the time in days between the first measurement,
which takes place within 24 h of initiation of PS ventilation, and successful
weaning (Twean). Successful weaning is defined as the patient being liberated
from mechanical ventilation at least 48 h without requiring resumption of MV.
Secondary outcome
Secondary outcome measures are ICU (TICU) and hospital stay (Thospital).
Background summary
Approximately 30% of the patients receiving mechanical ventilation (MV) in
intensive care units (ICUs) for more than two days have difficulties weaning,
which is directly related to both serious complications of invasive MV, and
poorer patient outcomes. The development of early prognostic factors that
acknowledge the complexity of weaning failure might help to address this
problem. However, the currently available parameters show no more than modest
accuracies in predicting weaning outcomes. To address this problem, the
authors propose an approach that takes the dynamically changing condition of
ventilated patients into account; 1) acquire physiological data over the
entire MV period in order to detect trends in patient status over time, and 2)
use more state-of-the-art data analysis methods, preserving more context in the
data and outcomes. Applied to the concept of breathing effort we propose to
study the interactions between the physiological systems involved in the
breathing; the neural respiratory drive and innervation, the respiratory muscle
dynamics, and the respiratory system mechanics. This approach might provide
more insight in the pathophysiological processes going on in a patient, and can
thus be used to guide MV management decisions throughout the entire weaning
process.
Study objective
The primary objective of this study is to investigate the relation between, on
the one hand, 1) the balance between the respiratory system mechanics and
muscle dynamics, and 2) the balance between the pressure support level and
respiratory drive, and, on the other hand, the weaning duration in patients
receiving prolonged mechanical ventilation.
Second, the effect of ventilatory support settings with respect to the optima
in these physiological relations on the weaning duration, and the progression
of these relations over the weaning duration are studied. Besides, the
relations of various weaning strategies and aids (e.g. nasal high flow therapy,
and inspiratory muscle training) with the course of the respiratory function
are investigated.
Study design
This is a monocentre observational study.
Study burden and risks
The studied problem is linked to ICU patients, as they are ventilated for
prolonged durations of time. This population is vulnerable by nature. However,
the risks related to prolonged mechanical ventilation, and the current lack of
good early prognostic factors, legitimate an observational study using a
non-invasive measurement protocol, posing only limited discomfort to the
patient, such that burdens and risks are minimised.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
1. Informed consent,
2. aged 18 years or older,
3. receiving or expected to receive invasive MV for >48h,
4. ventilated in pressure support mode,
5. SpO2 >= 90% (13),
6. FiO2 <= 60% (13),
7. 0 >= Richmond Agitation Sedation Scale (RASS-score) >= -4
Exclusion criteria
1. a medical history of neurological disease that might affect the respiratory
drive or neural conduction,
2. BMI > 30 kg/m²,
3. pregnant,
4. moribund,
5. persistent pneumothorax.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL75951.091.21 |