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

Completed

• Conditions: Ventilation Therapy; Complications
• Interventions: 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

• Registration Number: NCT03933332
• Lead Sponsor: Indonesia University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-12
• Status Verified: 2019-04
• Study First Submitted: 2019-04-27
• Study First Submitted QC: 2019-04-27
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventilator length of use	C-Reactive Protein (CRP) Level	measured in days
Ventilator length of use	Cross-sectional area of biceps brachii	measured in days
Ventilator length of use	Diaphragm thickness	measured in days
Ventilator length of use	Cross-sectional area of rectus femoris muscle	measured in days

Primary Outcome Measures

Name	Time	Method
Correlation between changes in diaphragm thickness with ventilator length of use	30 days from admission	Correlation between changes in diaphragm thickness with ventilator length of use: \< 7 days or \>7 days
Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use	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
Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use	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
Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use	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

Name	Time	Method
Changes in diaphragm thickness	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%
Changes in cross-sectional area of biceps brachii muscle	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%
Changes in quantitative C-reactive protein (CRP) levels	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%
Changes in cross-sectional area of rectus femoris muscle	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%
Ventilator length of use	30 days from admission	duration of first ventilator use until patient is extubated or deceased: \<7 days or \>7 days

Trial Locations

Locations (1)

Rumah Sakit Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia