The primary objective is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure. Furthermore, the hypothesis whether diaphragm efficiency (Effdi = electrical activity of…
ID
Source
Brief title
Condition
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are the diaphragm efficiency (Edi/Pdi) and tension time
index.
Secondary outcome
Not applicable.
Background summary
Mechanical ventilation offers essential ventilatory support during acute
respiratory failure. Unfortunately, mechanical ventilation is associated with
risks and complications and therefore, physicians aim to wean patients from the
ventilator as soon as the underlying reason for respiratory failure has
resolved. However, 20 - 30 % of intubated patients are difficult to wean from
mechanical ventilation, resulting in increased morbidity, mortality and health
care costs. The respiratory muscles drive ventilation with the diaphragm as the
most important inspiratory muscle. The capacity of the diaphragm of critically
ill patients is impaired by ICU-acquired muscle weakness. The combination of an
increased load imposed on the respiratory muscles and a reduced capacity to
generate pressure results in weaning failure. Although little discussion exists
as to whether respiratory muscles are weak in critically ill patients, the
development of muscle fatigue during a failed weaning trial is subject of
debate. Knowing whether or not patients develop respiratory muscle fatigue
would be of major help in planning the timing of the weaning process.
Study objective
The primary objective is to determine whether the diaphragm develops
contractile fatigue during a weaning trial and if this is associated with
weaning failure. Furthermore, the hypothesis whether diaphragm efficiency
(Effdi = electrical activity of the diaphragm (Edi)/ transdiaphragmatic
pressure (Pdi)) can be used as an objective predictor for weaning outcome will
be tested.
Study design
A prospective cohort pilot study in mechanically ventilated patients.
Study burden and risks
With the exception of the placement of the esophageal catheter no other
experimental interventions will be performed. Introduction of the esophageal
catheter may result in mild discomfort. No complications have been reported
with the introduction / use of this soft small bore catheter. Furthermore, in
the case that neurophysiological measurements have not been performed for
clinical reasons, this will be done so for the study purpose. Subjects have no
clinical benefits by participating in this study.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- age 18 year or older
- mechanical ventilation for at least 3 days
- the primary physician judges the patient to be ready to be weaned from the ventilator
- informed consent
Exclusion criteria
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.
- upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- recent (< 1 month) nasal bleeding
- phrenic nerve lesions
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 | NL31719.091.10 |