Body Impedance Analysis to Detect ICUAW

NCT ID: NCT05572138

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-01-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill patients

Body Impedance Analysis

Intervention Type DIAGNOSTIC_TEST

Body Impedance Analysis

Interventions

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Body Impedance Analysis

Body Impedance Analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Stefan J Schaller

Deputy Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité - Univiversitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
PMID: 25496103 (View on PubMed)

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.

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Reference Type BACKGROUND
PMID: 31970446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24108501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24531339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21276225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34284553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12472328 (View on PubMed)

Other Identifiers

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BIAMI

Identifier Type: -

Identifier Source: org_study_id

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