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

Not Applicable

• Conditions: Mechanical Ventilation Complication
• Interventions: Other: Tidal volume 10 ml/kg; Other: Tidal volume 6 ml/kg

• Registration Number: NCT05370248
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-04-28
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ten	Tidal volume 10 ml/kg	The group who received tidal volume of 10 ml/kg from mechanical ventilation
The six	Tidal volume 6 ml/kg	The group who received tidal volume of 6 ml/kg from mechanical ventilation

Primary Outcome Measures

Name	Time	Method
DD-48	48 hours after mechanical ventilation	Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
DD-24	24 hours after mechanical ventilation	Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
DD-72	72 hours after mechanical ventilation	Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.

Secondary Outcome Measures

Name	Time	Method
IL-6-48	48 hours after mechanical ventilation	Blook interleukin 6 48 hours after mechanical ventilation
IL-6-72	72 hours after mechanical ventilation	Blook interleukin 6 72 hours after mechanical ventilation
IL-6-24	24 hours after mechanical ventilation	Blook interleukin 6 24 hours after mechanical ventilation

Trial Locations

Locations (1)

Dr Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia