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NCT Number: NCT03933332

Correlation Between Muscle Thickness and Inflammation With Ventilator Use in Critically Ill Patients

Decrease thickness of diaphragm muscle, cross-sectional area of rectus femoris and biceps brachii muscle, and increase in CRP would affect ventilator length of use in critically ill patients in ICU

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Key information

Conditions

Ventilation Therapy; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who had Modified Rankin Score < 4 in 1 month before admitted into ICU

Exclusion criteria

  • Pregnant women
  • Patients who had intubation more than 24 hours before admitted at ICU Cipto Mangunkusumo Hospital
  • Patients who had a history or prior to thoracic or heart surgery 14 days before admission
  • Patients who had severe peripheral muscle dysfunction
  • Patients who had a history of admission in hospital for more than 2 weeks on the last 3 months
  • Patients who predicted will be using ventilator for less than 4 days
  • Patients who suffered acute respiratory distress syndrome (ARDS) with a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) less than 200
  • Patients who declined to participate in this study

Treatment and study plan

Diaphragm thickness

Other

measured at apposition zone using ultrasonography in mm

Cross-sectional area of rectus femoris muscle

Other

measured at lower one-third line between Spina iliaca anterior inferior (SIAI) and upper border femur patella using ultrasonography in cm^2

Cross-sectional area of biceps brachii

Other

measured at biceps brachii muscle using ultrasonography in cm^2

C-Reactive Protein (CRP) Level

Diagnostic Test

quantitative CRP using ELISA method in mcg/mL

Primary outcomes

  1. Correlation between changes in diaphragm thickness with ventilator length of use

    Time frame: 30 days from admission

    Correlation between changes in diaphragm thickness with ventilator length of use: < 7 days or >7 days

  2. Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use

    Time frame: 30 days from admission

    Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use: < 7 days or >7 days

  3. Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use

    Time frame: 30 days from admission

    Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use: < 7 days or >7 days

  4. Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use

    Time frame: 30 days from admission

    Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use: < 7 days or >7 days

Secondary outcomes

  1. Ventilator length of use

    Time frame: 30 days from admission

    duration of first ventilator use until patient is extubated or deceased: <7 days or >7 days

  2. Changes in diaphragm thickness

    Time frame: 5 days from admission

    Measurement of diaphragm thickness from day 1 admission to ICU using ventilator to day 5 in mm

    Score for changes in diaphragm thickness:

    0 : no changes

    • : decrease thickness of <20%
    • : decrease thickness of >20%

  3. Changes in cross-sectional area of rectus femoris muscle

    Time frame: 5 days from admission

    Measurement of cross-sectional area of rectus femoris muscle from day 1 admission to ICU using ventilator to day 5 in cm^2

    Score for changes in diaphragm thickness:

    0 : no changes

    • : decrease cross-sectional area of <20%
    • : decrease cross-sectional area of >20%

  4. Changes in cross-sectional area of biceps brachii muscle

    Time frame: 5 days from admission

    Measurement of cross-sectional area of biceps brachii muscle from day 1 admission to ICU using ventilator to day 5 in cm^2

    Score for changes in diaphragm thickness:

    0 : no changes

    • : decrease cross-sectional area of <20%
    • : decrease cross-sectional area of >20%

  5. Changes in quantitative C-reactive protein (CRP) levels

    Time frame: 5 days from admission

    Measurement of quantitative CRP from day 1 admission to ICU using ventilator to day 5 in mcg/mL

    Score for changes in diaphragm thickness:

    0 : no changes

    • : increase in quantitative CRP <50%
    • : increase in quantitative CRP >50%

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Correlation Between Muscle Thickness and Inflammation With Ventilator Length of Use in Critically Ill Patients: Study on Diaphragm Thickness, Rectus Femoris and Biceps Brachii Cross-sectional Area, and C-reactive Protein Level

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2019
Registry last updated
May 2, 2019

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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