An interventional study of Tidal volume 6 ml/kg and Tidal volume 10 ml/kg in Mechanical Ventilation Complication, sponsored by Dr Cipto Mangunkusumo General Hospital. Status unknown at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Other
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.
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.
Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The group who received tidal volume of 6 ml/kg from mechanical ventilation
Other: Tidal volume 6 ml/kg
The group who received tidal volume of 10 ml/kg from mechanical ventilation
Other: Tidal volume 10 ml/kg
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.
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.
DD-24
Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
Time frame: 24 hours after mechanical ventilation
DD-48
Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
Time frame: 48 hours after mechanical ventilation
DD-72
Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.
Time frame: 72 hours after mechanical ventilation
IL-6-24
Blook interleukin 6 24 hours after mechanical ventilation
Time frame: 24 hours after mechanical ventilation
IL-6-48
Blook interleukin 6 48 hours after mechanical ventilation
Time frame: 48 hours after mechanical ventilation
IL-6-72
Blook interleukin 6 72 hours after mechanical ventilation
Time frame: 72 hours after mechanical ventilation
Discharge outcome
The outcome at hospital discharge (alive or death)
Time frame: Up to three months after mechanical ventilation
LOS in hospital
Length of stay (days) in hospital
Time frame: Up to three months after mechanical ventilation
LOS in ICU
Length of stay (days) in ICU
Time frame: Up to three months after mechanical ventilation
Weaning failure
The condition where patient failed for spontaneous breathing trial after mechanical ventilation. Grouped into success/failed.
Time frame: Up to three months after mechanical ventilation
Intubation time
Time (hours) long when a patient was intubated
Time frame: At extubation after mechanical ventilation
Plan to share: No — IPD will not be shared since it is belong to the hospital and patient did not consent it to be published.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Dr Cipto Mangunkusumo General Hospital