Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Muscle wasting is a significant problem in critically ill patients, with reported losses of a half to three percent per day over the first ten days (for an average 70kg person this equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive care unit (ICU) and the loss of lean tissue have been associated with negative clinical outcomes, including increased incidence of infections, length of stay, mortality and muscle weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients with low muscularity on admission, 2) to help understand the factors impacting muscle loss and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass in this population.
The measurement of lean body mass in patients admitted to the ICU is challenging however, due to the large fluid shifts that occur in this population and logistical issues in moving patients to specialised machinery for body composition analysis. Currently, there is no validated method for accurately assessing a patient's muscle mass at the bedside in the intensive care setting. It is therefore important to investigate the accuracy, feasibility and reliability of bedside methods such as subjective physical assessment of muscle mass, mid arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this population who are primarily bedbound. In order to do this, a critical comparison is required between these methods and muscularity assessed by a "reference" body composition method, such computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the abdomen area utilising abdominal CT images has been shown to be highly representative of whole body skeletal muscle volume.
We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound, bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated with skeletal muscle mass quantified by a "reference method" (CT image analysis).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Aim Our primary aim is to investigate whether muscularity assessed via bedside ultrasound is correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in the first few days of critical illness.
Our secondary aims are
- To investigate whether muscularity assessed via other bedside methods (bioimpedance spectroscopy, subjective physical assessment and mid arm muscle circumference) are correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in critically ill patients.
- To better understand the association between measured resting energy expenditure and muscularity in the critically ill.
- To observe changes in skeletal muscle mass (in a sub set of patients who have two CT scans) and the impact various factors, including energy and protein delivery has on these changes.
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
-
-
Victoria
-
Melbourne, Victoria, 호주, 3004
- The Alfred Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Exclusion Criteria:
- CT scan performed >48hrs ago
- Death is imminent or deemed highly likely in the next 96 hours
- Are known to be pregnant
- Treating clinician does not believe the study to be in the best interest of the patient
- It is not possible to image two or more muscle groups via ultrasound (i.e. due to trauma, burns, wounds)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
기간: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
|
Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
기간: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
2차 결과 측정
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
기간: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
기간: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Mid arm muscle circumference (cm)
기간: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
기간: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
|
Measured resting energy expenditure (kilojoules)
기간: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
기간: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Kate Lambell, MNutrDiet, La Trobe University and Alfred Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Observational cohort에 대한 임상 시험
-
NCT07303218모집하지 않고 적극적으로비소세포폐암 | 상동 재조합 결핍 | PARP 억제제 | EGFR
-
NCT07359651모병연조직 감염 | Fournier 괴저 | 괴사성 근막염 | Fournier의 괴저
-
NCT07267091완전한낭창 | 루푸스 관절염 | 루푸스 관절염, 전신성 홍반성 루푸스 | 삶의 질(QOL)