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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Time frame: 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.
COMFORT score hour 0
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
Time frame: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
COMFORT score hour 6
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
Time frame: 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.
COMFORT score hour 12
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
Time frame: 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.
COMFORT score hour 18
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
Time frame: 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.
COMFORT score day 1 until 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
Time frame: 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.
COMFORT score extubation day
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
Time frame: 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.
Ventilator time
Time to extubation (days)
Time frame: 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.
Reintubation frequency
Number of times subject was reintubated within 48 hours after extubation
Time frame: 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.
Self extubation frequency
Number of times subject was self extubated during one episode of intubation
Time frame: 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.
PICU length of stay
Days from PICU admission to death or move outside the PICU to the ward
Time frame: 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.
Near infrared spectroscopy minute 5
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.
Time frame: The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-1
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.
Time frame: The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-6
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.
Time frame: The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
Near infrared spectroscopy hour-12
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.
Time frame: The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
Inotropic intervention
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
Time frame: The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
Vasoactive-Inotropic Score
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).
Time frame: 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