Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-18
Brief Title:
Skeletal Muscle Ultrasonography in Detection of Malnutrition
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome Among Critically Ill Children Attending Assiut University Children Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children
To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools
To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools
Detailed Description:
Under nutrition is a public health problem worldwide particularly among children under-five Globally in 2020 about 1492 million 22 of children under-five and 454 million 67 of children under-five were estimated to be stunted and wasted respectively Undernutrition equally accounts for about 31 million deaths 45 of all deaths among children under-five annually This burden however is disproportionately borne by the African continent In effect two out of five 41 or 614 million children stunted children and more than a quarter 27 or 121 million children of all wasted children under-five live in the African continent This burden varied across the country greatest in rural localities and areas with ongoing humanitarian crisis
Pediatric intensive care unit PICU admission rates for undernutrition in critically sick children range from 81 to 717 despite variations in nutritional indices the presence of chronic illness age and critical illness severity Critically ill children can become undernourished more quickly than adults due to their lower body fat and muscle mass and higher per kilogram resting energy requirements Complications from undernutrition can include more frequent infections longer length of stay LOS and morbidity
Underweight children admitted to the pediatric intensive care unit PICU have a higher mortality and PICU LOS which increase with increasing severity of underweight In light of this early detection of undernutrition and the observation of nutritional status degradation might result in fast and appropriate nutritional therapies which may improve clinical outcomes Additionally because most critically ill patients have reduced nutritional reserves iatrogenic underfeeding and increasing malnutrition are further encouraged by prolonged fasting and frequent feeding pauses during intensive care unit ICU and hospital stays No single objective marker can be used to reliably predict protein-energy malnutrition or risk of nutrition-related complications in children an assessment encompassing several markers is necessary The diagnosis of malnutrition can be based on 6 different domains 1 insufficient food and nutrition intake compared with nutrition requirements 2 weight loss over time 3 loss of muscle mass 4 loss of fat mass 5 fluid accumulation and 6 measurably diminished grip strength Hence no single measure either anthropometric or laboratory by itself is an ideal measure of malnutrition
Anthropometric measurements are essential components of nutrition screening and assessment of pediatric patients The use of proper equipment accurate measurement techniques and appropriate reference data are necessary for obtaining and interpreting anthropometric data Accurate height and length measurements can be difficult to obtain in ambulatory children and in some clinical situations such as trauma burn and surgical patients who require the use of traction castings or dressings for large body wounds accurate anthropometric measurements such as weight and height may be more difficult or impossible to obtain Preliminary evidence suggests that muscle wasting also occurs in critically ill children which could affect intensive care unit ICU course or long-term growth and development in children
Identification of muscle wasting would thus be important in critically ill children so as to be able to appropriately target optimal nutrition and physical interventions to reduce muscle wasting and risk of poor outcomes in these high-risk children However identifying muscle changes can be challenging in clinical practice Current methods available such as mid-arm circumference may not accurately reflect muscle changes while other methods such as computerized tomography CT or magnetic resonance imaging MRI are not easily conducted at bedside Recently ultrasonography has been used in adult critical care to visualize abnormalities and changes in muscle throughout the course of the ICU stay Ultrasonography an imaging technique that uses reflections of high-frequency sound waves directed at tissues is noninvasive fast and cost-effective and it has been suggested as a possible nutrition assessment tool in critically ill patients Muscle ultrasound enables early detection of skeletal muscle wasting which is associated with histological changes in muscle as well as functional impairment in adults Muscle ultrasonography has also traditionally been used to quantify and qualify muscle morphology in pediatric populations especially children with neuromuscular diseases
A necessary first step is identification of the most appropriate muscle group A variety of body sites have been studied in children the most common of which include the quadriceps gastrocnemius tibia biceps and forearm
Muscles are studied either individually eg rectus femoris or in combination with others eg rectus femoris and vastus intermedius in single or various limbs
Using a variety of muscle groups allowed for a more comprehensive assessment of whole-body nutrition assessment of children which required ultrasound measurement of both fat and muscle layer thickness MLT at 9 sites including anterior and posterior upper and lower limbs as well as subscapular and abdominal areas Equations using these measurements produced fat and muscle mass estimations comparable to that measured using more sophisticated imaging methods such as MRI and dual-energy x-ray absorptiometry DXA However as whole-body ultrasound measurements may require a significant amount of time some longitudinal studies have used single limbs for ultrasound measurements In children with cancer in whom reduced lean body mass could negatively affect disease outcomes monthly ultrasound demonstrated changes in quadriceps thickness throughout the course of cancer therapy This suggests that unlike in the diagnosis of neuromuscular disease a single muscle group may be sufficient to monitor changes in body composition over time in certain groups of pediatric patients
Both upper and lower body muscle wasting has been reported in critically ill childrenand some adult data suggest that muscle wasting affects lower limbs more than upper limbs
The quadriceps alone has also been used to monitor muscle changes in critically ill adults Measurements of the thickness of the rectus femoris vastus intermedius and vastus lateralis and cross-sectional area CSA of the rectus femoris on alternate days demonstrate an overall decreasing trend in the first 10 days of critical illnessThe quadriceps is the most commonly studied lower limb muscle in children
Loss of muscle mass is associated with poor clinical outcomes Patients who develop muscle wasting have higher risk of intensive care unit ICU acquired weakness increased length of ICU stay and loss of muscle mass during the frst week of ICU stay is associated with increased mortality risk Weakness and fatigue are persisting symptoms which have a negative impact on the quality of life of critical illness survivors
Thus muscle ultrasound may add benefit in early detection of undernutrition in practice so this study will be conducted to explore the accuracy of muscle ultrasound in detection of undernutrition in PICU in comparison to the traditional nutritional assessment tools and to explore its impact on prognosis of such cases
Pediatric intensive care unit PICU admission rates for undernutrition in critically sick children range from 81 to 717 despite variations in nutritional indices the presence of chronic illness age and critical illness severity Critically ill children can become undernourished more quickly than adults due to their lower body fat and muscle mass and higher per kilogram resting energy requirements Complications from undernutrition can include more frequent infections longer length of stay LOS and morbidity
Underweight children admitted to the pediatric intensive care unit PICU have a higher mortality and PICU LOS which increase with increasing severity of underweight In light of this early detection of undernutrition and the observation of nutritional status degradation might result in fast and appropriate nutritional therapies which may improve clinical outcomes Additionally because most critically ill patients have reduced nutritional reserves iatrogenic underfeeding and increasing malnutrition are further encouraged by prolonged fasting and frequent feeding pauses during intensive care unit ICU and hospital stays No single objective marker can be used to reliably predict protein-energy malnutrition or risk of nutrition-related complications in children an assessment encompassing several markers is necessary The diagnosis of malnutrition can be based on 6 different domains 1 insufficient food and nutrition intake compared with nutrition requirements 2 weight loss over time 3 loss of muscle mass 4 loss of fat mass 5 fluid accumulation and 6 measurably diminished grip strength Hence no single measure either anthropometric or laboratory by itself is an ideal measure of malnutrition
Anthropometric measurements are essential components of nutrition screening and assessment of pediatric patients The use of proper equipment accurate measurement techniques and appropriate reference data are necessary for obtaining and interpreting anthropometric data Accurate height and length measurements can be difficult to obtain in ambulatory children and in some clinical situations such as trauma burn and surgical patients who require the use of traction castings or dressings for large body wounds accurate anthropometric measurements such as weight and height may be more difficult or impossible to obtain Preliminary evidence suggests that muscle wasting also occurs in critically ill children which could affect intensive care unit ICU course or long-term growth and development in children
Identification of muscle wasting would thus be important in critically ill children so as to be able to appropriately target optimal nutrition and physical interventions to reduce muscle wasting and risk of poor outcomes in these high-risk children However identifying muscle changes can be challenging in clinical practice Current methods available such as mid-arm circumference may not accurately reflect muscle changes while other methods such as computerized tomography CT or magnetic resonance imaging MRI are not easily conducted at bedside Recently ultrasonography has been used in adult critical care to visualize abnormalities and changes in muscle throughout the course of the ICU stay Ultrasonography an imaging technique that uses reflections of high-frequency sound waves directed at tissues is noninvasive fast and cost-effective and it has been suggested as a possible nutrition assessment tool in critically ill patients Muscle ultrasound enables early detection of skeletal muscle wasting which is associated with histological changes in muscle as well as functional impairment in adults Muscle ultrasonography has also traditionally been used to quantify and qualify muscle morphology in pediatric populations especially children with neuromuscular diseases
A necessary first step is identification of the most appropriate muscle group A variety of body sites have been studied in children the most common of which include the quadriceps gastrocnemius tibia biceps and forearm
Muscles are studied either individually eg rectus femoris or in combination with others eg rectus femoris and vastus intermedius in single or various limbs
Using a variety of muscle groups allowed for a more comprehensive assessment of whole-body nutrition assessment of children which required ultrasound measurement of both fat and muscle layer thickness MLT at 9 sites including anterior and posterior upper and lower limbs as well as subscapular and abdominal areas Equations using these measurements produced fat and muscle mass estimations comparable to that measured using more sophisticated imaging methods such as MRI and dual-energy x-ray absorptiometry DXA However as whole-body ultrasound measurements may require a significant amount of time some longitudinal studies have used single limbs for ultrasound measurements In children with cancer in whom reduced lean body mass could negatively affect disease outcomes monthly ultrasound demonstrated changes in quadriceps thickness throughout the course of cancer therapy This suggests that unlike in the diagnosis of neuromuscular disease a single muscle group may be sufficient to monitor changes in body composition over time in certain groups of pediatric patients
Both upper and lower body muscle wasting has been reported in critically ill childrenand some adult data suggest that muscle wasting affects lower limbs more than upper limbs
The quadriceps alone has also been used to monitor muscle changes in critically ill adults Measurements of the thickness of the rectus femoris vastus intermedius and vastus lateralis and cross-sectional area CSA of the rectus femoris on alternate days demonstrate an overall decreasing trend in the first 10 days of critical illnessThe quadriceps is the most commonly studied lower limb muscle in children
Loss of muscle mass is associated with poor clinical outcomes Patients who develop muscle wasting have higher risk of intensive care unit ICU acquired weakness increased length of ICU stay and loss of muscle mass during the frst week of ICU stay is associated with increased mortality risk Weakness and fatigue are persisting symptoms which have a negative impact on the quality of life of critical illness survivors
Thus muscle ultrasound may add benefit in early detection of undernutrition in practice so this study will be conducted to explore the accuracy of muscle ultrasound in detection of undernutrition in PICU in comparison to the traditional nutritional assessment tools and to explore its impact on prognosis of such cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None