The primary objective is to investigate the coordination (functional and timing) between the different respiratory muscles in ICU patients under mechanical ventilation during assisted breathing and during a spontaneous breathing trial. To this end,…
ID
Source
Brief title
Condition
- Muscle disorders
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the coordination between the diaphragm and expiratory
muscles, quantified with 1) the pressure-time product (PTP) ratio of the
expiratory muscles versus total breathing PTP (PTPex/(PTPex +PTPin)), and 2) as
the activation pattern of the respiratory muscles using EMG.
More specific:
- Functional coordination will be assessed with the PTP: PTPex = PTP of the
expiratory muscles, as derived from Pga recordings during the expiratory phase
of breathing (PTPPga,ex).PTPin = PTP of the inspiratory muscles, as derived
from Pes recordings and the recoil pressure of the chest wall
- Timing coordination is the temporal phase relationship of sequential onset
and offset of different muscles (activation pattern), using the EMG-derived
phase angle.
Secondary outcome
Outcomes derived from study procedures:
- Thoracoabdominal synchrony, as derived from respiratory inductance
plethysmography bands.
- Electrical activity of the diaphragm as measured with a EAdi catheter (if
present) or with surface EMG
- Clinical and physiologically relevant parameters, such as ventilator settings
Background summary
Cooperation between inspiratory and expiratory muscles exists to maintain
adequate alveolar ventilation and such to satisfy the demands of breathing. The
diaphragm is the most important respiratory muscle and its capacity is often
impaired by ICU-acquired weaknesses. This is associated with adverse outcome,
including prolonged duration of mechanical ventilation and higher mortality. In
patients with high load of breathing or low inspiratory muscle capacity,
expiratory muscles are often recruited. However, the coordination between the
inspiratory and expiratory muscles is poorly understood and highly complex,
particularly during the expiratory phase of breathing and when the load imposed
on the respiratory muscles increases. In addition, the functional effects of
expiratory muscle recruitment are poorly understood.
Study objective
The primary objective is to investigate the coordination (functional and
timing) between the different respiratory muscles in ICU patients under
mechanical ventilation during assisted breathing and during a spontaneous
breathing trial. To this end, we 1) quantitate expiratory muscle effort using
the expiratory pressure-time-product derived from Pga recordings (PTPex), 2) we
define the relationship between PTPex and the total pressure-time-product of
the respiratory muscles (PTPtot = PTPex + PTPin) and 3) we define the
activation pattern of the respiratory muscles using sEMG.
Secondary objectives are:
- To evaluate the effects of an SBT on expiratory diaphragm activity
- To evaluate the effects of an SBT on thoracoabdominal synchrony as derived
from respiratory inductance plethysmography (RIP)
- To evaluate the correlation between PTPex and other parameters such as
surface electromyography (sEMG) of the abdominal wall muscles and their derived
parameters, RIP-derived endpoints, and clinical respiratory parameters
- To study whether the activation of the abdominal wall muscles and changes in
coordination have effects on weaning outcome
Study design
Observational physiological study
Study burden and risks
Placement of balloon catheters is a standard operational procedure in selected
ICU patients for the measurements respiratory muscle effort (i.e. severe acute
respiratory distress syndrome, difficult weaning, high risk for
ventilator-asynchronies). We will only enroll patients that already have such
catheter in situ. As such, there are no additional risks related to the
recordings obtained from this catheter.
All study procedures are non-invasive, or study parameters will be obtained
from routine care measurements / chart review.
In this study respiratory muscle monitoring procedures will be performed in a
structured manner during a period of 1 hour. Respiratory muscle weakness is
common in mechanically ventilated patients and is associated with prolonged
mechanical ventilation. Studying the effects of critical illness and mechanical
ventilation on the expiratory muscles and the coordination between the
inspiratory and expiratory muscles is therefore highly needed. Patients have no
direct benefit in participating in this study. However, the measurements of
esophageal and gastric pressure are available for the clinicians at the bedside
and study observations may be used to further optimize ventilator settings.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Informed consent
- Age > 18 years
- Invasive mechanical ventilation in assisted modes
- Dedicated feeding catheter (Nutrivent) in situ for measurements of
respiratory mechanics
Exclusion criteria
- Past history of neuromuscular disorders
- BMI > 30 kg/m2
- Drains/wounds limiting placement of EMG electrodes
- Anticipating withdrawal of life support and/or shift to palliation as the
goal of care
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 | NL62021.029.17 |