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Completed

NCT Number: NCT05572138

Body Impedance Analysis to Detect ICUAW

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Univiversitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Impedance Analysis

Diagnostic Test

Body Impedance Analysis

Primary outcomes

  1. Correlation: Skeletal muscle mass and MRC-Score

    Time frame: till Day 30

    The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score.

Secondary outcomes

  1. Correlation CSA and Skeletal muscle mass

    Time frame: till Day 30

    Cross sectional area of muscle ultrasound (M. rectus femoris) and Skeletal muscle mass (SMM) measured by BIA

  2. UCR : MRC correlation

    Time frame: till Day 30

    Correlation of urea-creatinine ratio in blood with MRC score.

  3. Kreatinin : MRC correlation

    Time frame: till Day 30

    Correlation of creatinine in blood with MRC score.

  4. IMS during the ICU stay

    Time frame: till Day 30 or ICU discharge

    achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)

  5. ICU mortality

    Time frame: till Day 30

    Mortality during ICU stay

  6. Duration of Mechanical ventilation

    Time frame: till Day 30

    Duration of invasive mechanical ventilator dependency

  7. Hospital mortality

    Time frame: till Day 30

    Mortality during Hospital stay

  8. ICU-LOS

    Time frame: till Day 30 (till ICU discharge)

    Length of stay in the ICU

  9. Hospital LOS

    Time frame: till Day 30 (till hospital discharge)

    Length of stay in the hospital

  10. in-hospital mortality

    Time frame: till Day 30 (till hospital discharge)

    Mortality during the Hospital stay

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: BIAMI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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