To optimize ventilator support in critically ill patients admitted to the intensive care unit by monitoring electromyography of the respiratory muscles.
ID
Source
Brief title
Condition
- Muscle disorders
- Neuromuscular disorders
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in activity of the respiratory muscles between the low and high
assist level in mechanically ventilated critically ill patients admitted to
the intensive care unit.
Secondary outcome
The difference in activity of the respiratory muscles between mechanical
ventilation and spontaneous breathing in critically ill patients admitted to
the intensive care uni
Background summary
For mechanical ventilation, assist modes are considered standard of care. In
these modes the contribution of the respiratory muscle activity of the patient
to the inspiratory support by the ventilator cannot be determined routinely.
This is of clinical importance as a high level of inspiratory support can lead
to suppression of muscle activity resulting in disuse atrophy. In contrast, a
low level of support can lead to muscle exhaustion. Electromyography (EMG) of
the respiratory muscles has been shown to provide an indicator of respiratory
loading/unloading in mechanically ventilated patients. In this study
electromyography of the respiratory muscles will be obtained to assess the load
of the muscles during the different levels of support ventilation. The load of
the respiratory muscles during support ventilation will be compared with the
load of the muscles obtained during spontaneous breathing trials.
Study objective
To optimize ventilator support in critically ill patients admitted to the
intensive care unit by monitoring electromyography of the respiratory muscles.
Study design
This study is set up as a crossover study. Respiratory variables, including
electromyography of the respiratory muscles will be acquired during a 120-min
trial. As ventilator support Neurally Adjusted Ventilatory Assist (NAVA) will
be used. Two levels of assist will be applied: a high assist level (tidal
volume 10-12 ml/kg) and a low assist level (tidal volume 6-8 ml/kg) will be
applied in random order. The effect of high and low assist on the activity of
the respiratory muscles will be compared.The load of the respiratory muscles
during NAVA will be compared with the load of the muscles obtained during
spontaneous breathing trials.
Intervention
Diagnostic interventions:
Surface Electromyography (sEMG) is a non-invasive technique used to measure
muscle activity. With sEMG signals of the respiratory muscles (diaphragm,
intercostal and scalene) can be obtained simultaneously without discomfort for
the patient. Eight ECG electrodes attached to the muscle sites and connected to
a wireless EMG recorder (Dipha-16, Inbiolab, Groningen) are used to obtain
signals.
Standard respiratory mechanics, including airway pressure, flow and volume
measurements, are obtained with the NICO monitor with the use of a measuring
device placed in the ventilator tubings (Philips Healthcare, Best, the
Netherlands).
Therapeutic interventions:
Two levels of assist will be applied: a high assist level (tidal volume 10-12
ml/kg) and a low assist level (tidal volume 6-8 ml/kg) will be applied in
random order.
A spontaneous breathing trial of at least 10 minutes and maximally 20 minutes
will be applied ..
Study burden and risks
Burden associated with participation: the application of extra EKG electrodes
for the sEMG measurements and the spontaneous breathing test. Risks: the
development of shortness of breath during the spontaneous breathing test.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
age >18 yr.
respiratory failure due to severe weakness of the respiratory muscles in absence of pulmonary disease (e.g. myasthenia, cervical spine injury)
respiratory failue de to severe weakness of the respiratory muscles with concomitant lung pathology (e.g. end stage ARDS, COPD and lung transplant)
ability to breathe spontaneously for 10 minutes
written informed consent
Exclusion criteria
Reduced respiratory drive and inability to breath spontaneously without ventilator support for > 10 minutes
Hemodynamic instability defined as blood pressure below 100 / 60 mmHg
Air leaks by cannula or chest tubes: defined as leaks above 1 liter per minute
Severe hypoxemia defined as paO2 below 8 kPa
Esophagus or neck surgery
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 | NL48434.078.14 |