Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation
- Sponsor
- Indonesia University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
- Last Updated
- 3 years ago
Overview
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
Investigators
Dr. dr. Antonius Hocky Pudjiadi, SpA(K)
Principal Investigator, Head of Pediatric Intensive Care Unit
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria
- •PICU admission due to post cardiac and respiratory arrest
Outcomes
Primary Outcomes
Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
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.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
Ventilator time
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.
Time to extubation (days)
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
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.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
COMFORT score day 1 until extubation
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.
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 18
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.
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
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.
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 0
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.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
COMFORT score hour 12
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.
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 12
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.
Pain scoring. Each characteristic has 0-2 points with maximum 10 points. The greater number indicate greater pain score.
COMFORT score hour 6
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.
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
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.
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
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.
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 0
Time Frame: 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
Secondary Outcomes
- Near infrared spectroscopy minute 5(The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.)
- Near infrared spectroscopy hour-6(The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.)
- Near infrared spectroscopy hour-12(The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.)
- Inotropic intervention(The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.)
- 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.)
- 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.)
- 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.)
- Near infrared spectroscopy hour-1(The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.)
- 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)