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

• ClinicalTrials.gov Identifier: NCT03933332
• Recruitment Status: Completed
• First Posted: May 1, 2019
• Last Update Posted: May 2, 2019
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Dita Aditianingsih, Indonesia University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Ventilation Therapy; Complications	Other: Diaphragm thickness; Other: Cross-sectional area of rectus femoris muscle; Other: Cross-sectional area of biceps brachii; Diagnostic Test: C-Reactive Protein (CRP) Level

Study Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: January 31, 2019
• Actual Study Completion Date: March 12, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

   1. : decrease thickness of <20%
   2. : 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

   1. : decrease cross-sectional area of <20%
   2. : 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

   1. : decrease cross-sectional area of <20%
   2. : 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

   1. : increase in quantitative CRP <50%
   2. : increase in quantitative CRP >50%

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Indonesia

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Sponsors and Collaborators

Indonesia University

More Information

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• Responsible Party: Dita Aditianingsih, MD, PhD, Anesthesiologist Consultant, Indonesia University
• ClinicalTrials.gov Identifier: NCT03933332
• Other Study ID Numbers: IndonesiaUAnes036
• First Posted: May 1, 2019
• Last Update Posted: May 2, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Inflammation; Pathologic Processes