To evaluate whether neuromuscular ultrasound discriminates between patients with and without ICU-AW.To detect differences between patients that do and do not have ICU-AW in order to determine relevant cut-offs which can be used in future diagnostic…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in gray-scale value as measures of echointensity on standardized
cross-sectional ultrasonographic views of five muscle groups on one side
(biceps brachii, forearm flexor group, quadriceps femoris, tibialis anterior,
and diaphragm) in patients with ICU-AW and patients without ICU-AW.
Secondary outcome
- Differences in standard deviation of the gray scale values as a measure of
homogeneity of the five muscle groups (biceps brachii, forearm flexor group,
quadriceps femoris, tibialis anterior, and diaphragm) between patients with
ICU-AW and patients without ICU-AW.
- Differences in cross-sectional muscle thickness as measure of muscle atrophy
of the five muscle groups (biceps brachii, forearm flexor group, quadriceps
femoris, tibialis anterior, and diaphragm) between patients with ICU-AW and
patients without ICU-AW.
- Differences in vascularity of the five muscle groups (biceps brachii, forearm
flexor group, quadriceps femoris, tibialis anterior, and diaphragm) between
patients with ICU-AW and patients without ICU-AW.
- Differences in gray*scale value and area and vascularity on standardized
cross-sectional ultrasonographic views of median nerve and peroneal nerve (at
one side) between patients with ICU-AW and patients without ICU-AW.
- Patient and control characteristics: age, sex, body weight, length, medical
history, pre-admission performance.
- Clinical data: illness severity, diagnosis, laboratory data, microbiological
data, radiological data, strength measurements.
- Number of patients and controls with indeterminate results, missing results
and outliers of the index test.
Background summary
Intensive Care Unit-acquired weakness (ICU-AW), a frequently occurring
complication of critical illness, can be caused by muscle dysfunction (critical
illness myopathy; CIM), nerve dysfunction (critical illness polyneuropathy;
CIP) or a combination (critical illness neuromyopathy; CINM). Differentiation
between these disorders is difficult with current diagnostic methods.
Ultrasound examination of the neuromuscular system has been shown to improve
diagnostic accuracy in various neuromuscular diseases and have brought new
insights in the pathophysiology of these diseases. However, diagnostic accuracy
of ultrasound examination for ICU-AW has not been investigated. As an initial
step, we will perform a prospective cross-sectional study, in which we will
assess patients admitted at the ICU with critical illness who require
mechanical ventilation for at least two days. When patient cooperation allows,
the reference standard will be strength monitoring according to the medical
research council scale to assess the presence of ICU-AW as part of routine
care. Next, blinded to the reference standard, neuromuscular ultrasound
examination will be performed. If this initial study shows that ultrasound is
able to discriminate between patients with and without ICU-AW, the next step
will be ultrasound monitoring before strength assessment is feasible to assess
whether ultrasound parameters are able to predict ICU-AW at an early stage.
Study objective
To evaluate whether neuromuscular ultrasound discriminates between patients
with and without ICU-AW.
To detect differences between patients that do and do not have ICU-AW in order
to determine relevant cut-offs which can be used in future diagnostic accuracy
studies to discriminate between these patient groups.
Study design
Prospective, cross-sectional survey of the study population
Study burden and risks
ICU-AW can only be investigated in the intensive care. Ultrasound is a
non-invasive, painless, and harmless investigation, which can be performed at
the bedside at the ICU, thus having a negligible risk and burden for the
patient. Also patients with in-dwelling metals such as pacemakers can be
evaluated without any harm. The investigations will take around 45 min. The
ultrasound technique has proven its usefulness in several neuropathies and
myopathies, but as yet has been sparsely studied in critical illness. Although
the participants of this study will not benefit from this study, the possible
future improvement of the diagnostic process of ICU-AW can lead to tailored
care. The need for rehabilitation, the avoidance for medication detrimental to
muscle or nerve and early tracheostomy are examples of possible benefits when
ultrasound may be able to differentiate between patients who do and do not
develop ICU-AW.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
Adult patients newly admitted to the ICU of the Academic Medical Center
- Mechanical ventilation for at least 48 hours
- Diagnosis of ICU-AW or absence of ICU-AW, according to consensus guidelines, made by physical therapist as part of routine care
- At least one arm and one leg available for testing
Exclusion criteria
Neuromuscular disorder as reason for admission; Stroke (ischemic, hemorrhagic or subarachnoid) as reason for admission; Quadriplegia due to spinal cord syndrome in medical history or as reason for admission; Out of hospital cardiac arrest as reason for admission; Traumatic brain injury as reason for admission
Known intracerebral space occupying lesion
Poor functional status before admission (modified Rankin score 4 or 5)
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 | NL41156.018.12 |
| OMON | NL-OMON27105 |