Mechanical Ventilation Complication
Conditions
Keywords
Mechanical ventilation, Diaphragm dysfunction
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.
Interventions
OTHERTidal volume 6 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.
OTHERTidal 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.
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants are blinded to which group they belong and they have given consent to that. The person assigning patients to each group is the research assistant. The person setting the mechanical ventilator is the anesthesiology resident. The person assessing outcome with ultrasound is radiology department staff, who does not know which group the patient belong. The person assessing outcome of interleukin is laboratory personnel, who does not know which group the patient belong. The person collecting and freezing data into worksheet is the research assistant. The person analyzing final data is the primary investigator.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| DD-48 | 48 hours after mechanical ventilation | Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6-24 | 24 hours after mechanical ventilation | Blook interleukin 6 24 hours after mechanical ventilation |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| LOS in ICU | Up to three months after mechanical ventilation | Length of stay (days) in ICU |
| LOS in hospital | Up to three months after mechanical ventilation | Length of stay (days) in hospital |
| Weaning failure | Up to three months after mechanical ventilation | The condition where patient failed for spontaneous breathing trial after mechanical ventilation. Grouped into success/failed. |
| Intubation time | At extubation after mechanical ventilation | Time (hours) long when a patient was intubated |
| Discharge outcome | Up to three months after mechanical ventilation | The outcome at hospital discharge (alive or death) |
Countries
Indonesia
Outcome results
None listed