|- candidate number||15180|
|- NTR Number||NTR4148|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jul-2013|
|- Secondary IDs||NL41156.018.12 METC Academic Medical Center, Amsterdam|
|- Public Title||Neuromuscular ultrasound in patients with and without ICU-acquired weakness|
|- Scientific Title||Neuromuscular Ultrasound in Critical Illness |
|- hypothesis||Neuromuscular ultrasound can discriminate between patients with and without ICU-AW|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||-Adult patients newly admitted to the ICU |
-Mechanical ventilation for at least 48 hours
-Feasible evaluation of ICU-AW according to international standard with the MRC scale
|- 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)
- >= 2 extremities available for testing
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||17-sep-2013|
|- planned closingdate||17-mrt-2015|
|- Target number of participants||80|
|- Interventions||Muscle strength will be investigated by the attending physiotherapist, using the Medical Research Council (MRC) sumscore to assess the presence of ICU-AW.
Next, blinded to the strength evaluation, neuromuscular ultrasound examination will be performed.|
|- Primary outcome||Difference in gray-scale value as measures of echointensity on standardized cross-sectional ultrasonographic views of five muscle groups 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 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 between patients with ICU-AW and patients without ICU-AW.
- Differences in area and vascularity on standardized ultrasonographic views of median nerve and peroneal nerve.
|- Timepoints||Single timepoint for neuromuscular ultrasound just after valid muscle strength assessment|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. C. Verhamme|
|- CONTACT for SCIENTIFIC QUERIES||MD. C. Verhamme|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Intensive Care, Academic Medical Center (AMC), Department of Neurology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Neurology, Academic Medical Center (AMC), Department of Intensive Care|
|- Brief summary||Intensive Care Unit-acquired weakness (ICU-AW), a frequently occurring complication of critical illness. Ultrasound examination of the neuromuscular system has been shown to improve diagnostic accuracy in various neuromuscular diseases. However, diagnostic accuracy of ultrasound examination for ICU-AW has not been investigated. |
The aim of this study is to evaluate whether neuromuscular ultrasound discriminates between patients with and without ICU-AW.
In this prospective cross-sectional survey, adult patients admitted to the ICU of the Academic Medical Center, who require mechanical ventilation for at least two days, will be included. The presence of ICU-AW will be assessed by the attending physiotherapist, using the Medical Research Council score. Thereafter, an extensive neuromuscular ultrasound examination will be performed.
The main study endpoint is the difference in gray-scale value, as measures of echointensity, on standardized cross-sectional ultrasonographic views of five muscle groups in patients with ICU-AW and patients without ICU-AW.
|- Main changes (audit trail)|
|- RECORD||23-jul-2013 - 27-feb-2016|