Mechanical Ventilation, Sedation
Conditions
Brief summary
This research is a single-blinded, randomized controlled trial involving mechanically ventilated children in Pediatric Intensive Care Unit, Cipto Mangunkusumo Hospital, Indonesia. Subjects were divided into two groups: intervention vs control group. Primary and secondary outcomes will be measure pre, during, and post treatment.
Detailed description
As of today, there is no sedation and ventilator weaning protocol in our PICU. Decision for sedation and ventilator weaning were based on attending physicians clinical judgement, which greatly varies among individual. Previous study on the use of these protocols showed a favorable outcome. We aim to assess the safety and effectiveness of this protocol in our PICU. Subjects were recruited consecutively and randomized into intervention and control group. * Intervention group: sedation and ventilator weaning protocol * Control group: no protocol Primary outcomes: * FLACC score * COMFORT score * Ventilator days Secondary outcomes: * Self extubation * Reintubation * PICU Length of stay * Frequency of asynchrony * NIRS value * VIS score
Interventions
OTHERSedation and ventilator weaning protocol
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patient who need mechanical ventilation for more than 12 hours
Exclusion criteria
* PICU admission due to post cardiac and respiratory arrest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator time | From intubation to extubation which would not need reintubation within 48 hours of extubation, measurement of the time frame may be assessed up to 28 days measured from intubation time. | Time to extubation (days) |
| Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18 | FLACC scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
| Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation | Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
| Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day | This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
| COMFORT score hour 0 | This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| COMFORT score hour 6 | COMFORT scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| COMFORT score hour 12 | COMFORT scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| COMFORT score hour 18 | COMFORT scoring of hour 18 will be measured 18 hours after hour 0 was measured. Hour 18 is measured from the time the subject was intubated. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| COMFORT score day 1 until extubation | Scoring will be assessed every morning. If the subject was intubated at night, scoring for day 1 will be measured in the morning the day after tomorrow. Thereafter, the measurement will be taken every morning, 24 hour apart until the subject extubation. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| COMFORT score extubation day | This score will be taken when the subject was stopped from all sedative and analgetics, just before extubation. Monitoring of extubation will be conducted until 56 days after initial intubation. | Sedation scoring. It consists of 8 components. Each component has a score of 1-5, max score 40. Scores of 8 - 17 are over-sedated, scores between 17 - 26 are adequately sedated, and scores between 27 - 40 are under-sedated |
| Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0 | every 6 hours for the first 24 hours, once daily until extubation. This is the baseline. Once the patient was intubated, FLACC scoring of hour 0 will be assessed and noted. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
| Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6 | FLACC scoring of hour 6 will be measured 6 hours after hour 0 was measured. Hour 6 is measured from the time the subject was intubated. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
| Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12 | FLACC scoring of hour 12 will be measured 12 hours after hour 0 was measured. Hour 12 is measured from the time the subject was intubated. | Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self extubation frequency | Frequency of self extubation by the patient during one episode of intubation. Assessment will be noted up to 28 days measured from the first time intubation was performed. | Number of times subject was self extubated during one episode of intubation |
| PICU length of stay | Length of stay in PICU from admission until patient's death or step-down to the pediatric ward. Assessment of PICU length of stay will be noted up to 56 days measured from the first day of PICU admission as day 1. | Days from PICU admission to death or move outside the PICU to the ward |
| Near infrared spectroscopy minute 5 | The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation. | Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury. |
| Near infrared spectroscopy hour-1 | The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation. | Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury. |
| Near infrared spectroscopy hour-6 | The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation. | Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury. |
| Near infrared spectroscopy hour-12 | The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation. | Value of Near infrared spectroscopy (NIRS) during minute 5 after administration of sedatives or analgetic. NIRS values of less than 40% for 10 minutes or a 20% decrease from baseline indicated anaerobic metabolism and ischemic brain injury. |
| Inotropic intervention | The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days. | All inotropes used will be noted as secondary outcome to identify the hypotensive and/or bradycardia complications that might be caused due to usage of sedatives and analgesia. The usage will be divided into two categories: Yes and No usage of inotrope |
| Vasoactive-Inotropic Score | The VIS score will be measured once during PICU admission up to 14 days of mechanical ventilation days.. The highest value will be recorded and categorized into two groups | The VIS were extracted from the formula: dopamine dose (μg/kg/minute) + dobutamine dose (μg/kg/minute) + 100 x epinephine dose (μg/kg/minute) + 10 x milrinone dose (μg/kg/minute) + 10,000 x vasopressine dose (unit/kg/minute) + 100 x norepinefrine dose (μg/kg/minute). The VIS score was categorized into two (≥20 dan \<20). |
| Reintubation frequency | Frequency of subject who are extubated to be reintubated within 48 hours after extubation. Assessment will be noted up to 28 days measured from the first time intubation was performed. | Number of times subject was reintubated within 48 hours after extubation |
Countries
Indonesia
Outcome results
None listed