The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient

Study Overview
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Brief Summary
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This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.

Detailed Description
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Patient was enrolled in the first day receiving mechanical ventilation in ICU. Patient was included to group A or group B. Group A patient will receive tidal volume of 6 ml/kg and group B patient will receive tidal volume of 10 ml/kg. The assignment was randomized. Followed for 3 days. After 24, 48, and 72 hours, patient blood will be collected to measure the interleukin value, and diaphragm dysfunction will be observed by the use of ultrasonography by expert doctor from radiology department. Data will be analyzed statistically if there is an effect of tidal volume difference on diaphragm dysfunction and interleukin-6 as marker of inflammation. The minimal sample of patient is 44 patients.

Official Title
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The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Tidal volume 6 ml/kg
* Other: Tidal volume 10 ml/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age 18 years old Critically ill patients Exclusion Criteria: Patient with ARDS (PaO2/FiO2 <200) Pregnant woman Patient with history of cardiac or thorax surgery 14 days prior to admission Patient with severe peripheral musculoskeletal conditions Patient with prolonged in-hospital stay (>2 weeks) in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient was divided into group A and B. Group A received tidal volume of 6 ml/kg and group B received tidal volume of 10 ml/kg.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The six<br>The group who received tidal volume of 6 ml/kg from mechanical ventilation | Other: Tidal volume 6 ml/kg<br>* Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.<br>|
| Active Comparator: The ten<br>The group who received tidal volume of 10 ml/kg from mechanical ventilation | Other: Tidal volume 10 ml/kg<br>* Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DD-24 | Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound. | 24 hours after mechanical ventilation | 
| DD-48 | Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound. | 48 hours after mechanical ventilation | 
| DD-72 | Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound. | 72 hours after mechanical ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6-24 | Blook interleukin 6 24 hours after mechanical ventilation | 24 hours after mechanical ventilation | 
| IL-6-48 | Blook interleukin 6 48 hours after mechanical ventilation | 48 hours after mechanical ventilation | 
| IL-6-72 | Blook interleukin 6 72 hours after mechanical ventilation | 72 hours after mechanical ventilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Diaphragm dysfunction