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

April 30, 2019 updated by: Dita Aditianingsih, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically-ill patients admitted to Intensive Care Units of Cipto Mangunkusumo Hospital using ventilator on October 2018 - December 2018

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ventilator length of use
measured in days
Other: Diaphragm thickness
measured at apposition zone using ultrasonography in mm
Other: Cross-sectional area of rectus femoris muscle
measured at lower one-third line between Spina iliaca anterior inferior (SIAI) and upper border femur patella using ultrasonography in cm^2
Other: Cross-sectional area of biceps brachii
measured at biceps brachii muscle using ultrasonography in cm^2
Diagnostic test: C-Reactive Protein (CRP) Level
quantitative CRP using ELISA method in mcg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days from admission
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
30 days from admission
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
30 days from admission
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
30 days from admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days from admission
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

  1. : decrease thickness of <20%
  2. : decrease thickness of >20%
5 days from admission
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

  1. : decrease cross-sectional area of <20%
  2. : decrease cross-sectional area of >20%
5 days from admission
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

  1. : decrease cross-sectional area of <20%
  2. : decrease cross-sectional area of >20%
5 days from admission
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

  1. : increase in quantitative CRP <50%
  2. : increase in quantitative CRP >50%
5 days from admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 12, 2019

Study Registration Dates

First Submitted

April 27, 2019

First Submitted That Met QC Criteria

April 27, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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