Body Impedance Analysis to Detect ICUAW (BIAMI)

Body Impedance Analysis to Detect Muscle Strength Associated With ICU Acquired Weakness

The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated.

The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Diagnostic test: Body Impedance Analysis

Detailed Description

Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. It develops in approximately 40% of all ICU patients, which corresponds to at least 1.2 million patients annually in Germany. All these patients face a wide spectrum of sequelae and increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after ICU admission.

ICUAW is currently diagnosed by the MRC score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). Manual muscle testing (MMT) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. In addition, there is a possible discrepancy by different observers. As a result, early detection of ICUAW may be inadequate in most patients and unreliable during critical illness.

Measurement by BIA is reproducible, so differences in measurement can be attributed to changes in clinical condition. Body impedance analysis thus demonstrates a means of objective measurement.

Thus, the study aims to counteract the long-term consequences of ICUAW through early detection of ICUAW by allowing countermeasures to be taken earlier.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Univiversitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

critically ill invasively ventilated patients

Description

Inclusion Criteria:

- Patients aged ≥ 18 years with ventilatory support within 36 hours from ICU admission.

Exclusion Criteria:

• With a language barrier
• Patients with pacemaker or other electronic implant
• Expected death or discontinuation of life-sustaining measures.
• Not walking independently before hospitalization (gait aids allowed)
• Allergy to electrode gel
• BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients	Diagnostic test: Body Impedance Analysis; Body Impedance Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation: Skeletal muscle mass and MRC-Score	The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score.	till Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation CSA and Skeletal muscle mass	Cross sectional area of muscle ultrasound (M. rectus femoris) and Skeletal muscle mass (SMM) measured by BIA	till Day 30
UCR : MRC correlation	Correlation of urea-creatinine ratio in blood with MRC score.	till Day 30
Kreatinin : MRC correlation	Correlation of creatinine in blood with MRC score.	till Day 30
IMS during the ICU stay	achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)	till Day 30 or ICU discharge
ICU mortality	Mortality during ICU stay	till Day 30
Duration of Mechanical ventilation	Duration of invasive mechanical ventilator dependency	till Day 30
Hospital mortality	Mortality during Hospital stay	till Day 30
ICU-LOS	Length of stay in the ICU	till Day 30 (till ICU discharge)
Hospital LOS	Length of stay in the hospital	till Day 30 (till hospital discharge)
in-hospital mortality	Mortality during the Hospital stay	till Day 30 (till hospital discharge)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Stefan J Schaller, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
• De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
• Hough CL, Lieu BK, Caldwell ES. Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement. Crit Care. 2011;15(1):R43. doi: 10.1186/cc10005. Epub 2011 Jan 28.
• Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
• Fan E, Cheek F, Chlan L, Gosselink R, Hart N, Herridge MS, Hopkins RO, Hough CL, Kress JP, Latronico N, Moss M, Needham DM, Rich MM, Stevens RD, Wilson KC, Winkelman C, Zochodne DW, Ali NA; ATS Committee on ICU-acquired Weakness in Adults; American Thoracic Society. An official American Thoracic Society Clinical Practice guideline: the diagnosis of intensive care unit-acquired weakness in adults. Am J Respir Crit Care Med. 2014 Dec 15;190(12):1437-46. doi: 10.1164/rccm.201411-2011ST.
• Savalle M, Gillaizeau F, Maruani G, Puymirat E, Bellenfant F, Houillier P, Fagon JY, Faisy C. Assessment of body cell mass at bedside in critically ill patients. Am J Physiol Endocrinol Metab. 2012 Aug 1;303(3):E389-96. doi: 10.1152/ajpendo.00502.2011. Epub 2012 May 29.
• Appleton RT, Kinsella J, Quasim T. The incidence of intensive care unit-acquired weakness syndromes: A systematic review. J Intensive Care Soc. 2015 May;16(2):126-136. doi: 10.1177/1751143714563016. Epub 2014 Dec 18.
• Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.
• Wollersheim T, Woehlecke J, Krebs M, Hamati J, Lodka D, Luther-Schroeder A, Langhans C, Haas K, Radtke T, Kleber C, Spies C, Labeit S, Schuelke M, Spuler S, Spranger J, Weber-Carstens S, Fielitz J. Dynamics of myosin degradation in intensive care unit-acquired weakness during severe critical illness. Intensive Care Med. 2014 Apr;40(4):528-38. doi: 10.1007/s00134-014-3224-9. Epub 2014 Feb 15.
• Gijsen M, Simons E, De Cock P, L N G Malbrain M, Wauters J, Spriet I. Reproducibility of fluid status measured by bioelectrical impedance analysis in healthy volunteers: a key requirement to monitor fluid status in the intensive care unit. Anaesthesiol Intensive Ther. 2021;53(3):193-199. doi: 10.5114/ait.2021.105826.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): January 28, 2024
• Study Completion (Actual): January 28, 2024

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: BIAMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No