Sedation and Ventilator Weaning Protocol in PICU
9 de junio de 2022 actualizado por: Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Indonesia University
Effectiveness of Sedation and Ventilator Weaning Protocol - a Randomized Controlled Trial
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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria:
- PICU admission due to post cardiac and respiratory arrest
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sedation and Ventilator Weaning Protocol
Sedation: start midazolam 5-10 mins (max 3x). If MV 12 hrs-2d: Pain: morphine @2 hrs if needed (max 10mg/x). Sedation: midazolam @ 1-2 hrs if needed (max 10mg/x). If MV >2 d: morphine & midazolam drip (max 10mg/hr). MV weaning checklist @morning. Pass if no incr of sedation dose due to agitation, NMBAs, incr in ICP. Fail: reassessed tomorrow. Pain and SBS scores assessed @morning until extubation. Stop all sedation and analgetic for sedation. Continue analgetics for pain. Subjects monitored for 4 hrs. Assess pain and WAT-1 score. Pass (GCS of E3, tolerate sedation interruption for > 4 hrs): MV weaning protocol. Fail (Persistent anxiety/agitation, incr pain score, incr RR > 5 mins, SpO2 <88% >5 mins, acute heart dysrhythmia, >=2 signs of ARDS): sedation resumed ½ dose, up titrated. MV weaning: CPAP 5/PS < 7. Pass: No failure criteria for 2 hrs. Fail (Incr RR > 5 mins, SpO2 <88% > 5 mins, acute decr in GCS/acute heart dysrhythmia, >=2 signs of ARDS): previous MV setting. |
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
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Sin intervención: Control
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Periodo de tiempo: 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.
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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 6
Periodo de tiempo: 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.
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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
Periodo de tiempo: 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.
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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
Periodo de tiempo: 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.
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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
Periodo de tiempo: 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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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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
Periodo de tiempo: 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.
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Pain scoring.
Each characteristic has 0-2 points with maximum 10 points.
The greater number indicate greater pain score.
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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.
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COMFORT score hour 0
Periodo de tiempo: This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
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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
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This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
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COMFORT score hour 6
Periodo de tiempo: 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.
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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
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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.
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COMFORT score hour 12
Periodo de tiempo: 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.
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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
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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.
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COMFORT score hour 18
Periodo de tiempo: 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.
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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
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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.
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COMFORT score day 1 until extubation
Periodo de tiempo: 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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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
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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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COMFORT score extubation day
Periodo de tiempo: 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.
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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
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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.
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Ventilator time
Periodo de tiempo: 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.
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Time to extubation (days)
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reintubation frequency
Periodo de tiempo: 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.
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Number of times subject was reintubated within 48 hours after extubation
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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.
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Self extubation frequency
Periodo de tiempo: 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.
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Number of times subject was self extubated during one episode of intubation
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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.
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PICU length of stay
Periodo de tiempo: 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.
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Days from PICU admission to death or move outside the PICU to the ward
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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.
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Near infrared spectroscopy minute 5
Periodo de tiempo: The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
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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.
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The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
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Near infrared spectroscopy hour-1
Periodo de tiempo: The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
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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.
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The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
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Near infrared spectroscopy hour-6
Periodo de tiempo: The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
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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.
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The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
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Near infrared spectroscopy hour-12
Periodo de tiempo: The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
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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.
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The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
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Inotropic intervention
Periodo de tiempo: The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
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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
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The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
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Vasoactive-Inotropic Score
Periodo de tiempo: 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
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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).
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Antonius H. Pudjiadi, MD, PhD, Indonesia University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2020
Finalización primaria (Actual)
1 de enero de 2022
Finalización del estudio (Anticipado)
1 de julio de 2022
Fechas de registro del estudio
Enviado por primera vez
13 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2021
Publicado por primera vez (Actual)
9 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2022
Última verificación
1 de junio de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20030379
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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