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

Dr Cipto Mangunkusumo General Hospital

Status: Unknown

Conditions: Mechanical Ventilation Complication

Treatments: Other: Tidal volume 6 ml/kg; Other: Tidal volume 10 ml/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT05370248

DPS1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

The six

Experimental group

Description:

The group who received tidal volume of 6 ml/kg from mechanical ventilation

Treatment:

Other: Tidal volume 6 ml/kg

The ten

Active Comparator group

Description:

The group who received tidal volume of 10 ml/kg from mechanical ventilation

Treatment:

Other: Tidal volume 10 ml/kg