Clinical trial NCT03933332: Correlation Between Muscle Thickness and Inflammation With Ventilator Use in Critically Ill Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation Therapy; Complications
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility 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

Primary outcomes:
measure: Correlation between changes in diaphragm thickness with ventilator length of use
timeFrame: 30 days from admission
measure: Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use
timeFrame: 30 days from admission
measure: Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use
timeFrame: 30 days from admission
measure: Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use
timeFrame: 30 days from admission
Secondary outcomes:
measure: Ventilator length of use
timeFrame: 30 days from admission
measure: Changes in diaphragm thickness
timeFrame: 5 days from admission
measure: Changes in cross-sectional area of rectus femoris muscle
timeFrame: 5 days from admission
measure: Changes in cross-sectional area of biceps brachii muscle
timeFrame: 5 days from admission
measure: Changes in quantitative C-reactive protein (CRP) levels
timeFrame: 5 days from admission
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References:
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