Sedation and Ventilator Weaning Protocol in PICU
9 июня 2022 г. обновлено: 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.
Обзор исследования
Статус
Активный, не рекрутирующий
Условия
Вмешательство/лечение
Подробное описание
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
Тип исследования
Интервенционный
Регистрация (Действительный)
50
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Индонезия, 10430
- Cipto Mangunkusumo Hospital
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 1 месяц до 17 лет (Ребенок)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria:
- PICU admission due to post cardiac and respiratory arrest
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Без вмешательства: Control
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
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.
|
|
Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
Временное ограничение: 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.
|
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
Временное ограничение: 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
|
This is the baseline. Once the patient was intubated, COMFORT scoring of hour 0 will be assessed and noted.
|
|
COMFORT score hour 6
Временное ограничение: 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 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
Временное ограничение: 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 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
Временное ограничение: 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 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
Временное ограничение: 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
|
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
Временное ограничение: 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
|
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
Временное ограничение: 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)
|
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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Reintubation frequency
Временное ограничение: 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
|
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
Временное ограничение: 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
|
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
Временное ограничение: 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
|
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
Временное ограничение: 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.
|
The scoring will be noted during minute-5 after sedatives/analgetic administration following intubation.
|
|
Near infrared spectroscopy hour-1
Временное ограничение: 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.
|
The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
|
|
Near infrared spectroscopy hour-6
Временное ограничение: 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.
|
The scoring will be noted during hour-6 after sedatives/analgetic administration following intubation.
|
|
Near infrared spectroscopy hour-12
Временное ограничение: 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.
|
The scoring will be noted during hour-12 after sedatives/analgetic administration following intubation.
|
|
Inotropic intervention
Временное ограничение: 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
|
The inotropic intervention will be noted throughout PICU admission up to 14 days of mechanical ventilation days.
|
|
Vasoactive-Inotropic Score
Временное ограничение: 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).
|
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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Antonius H. Pudjiadi, MD, PhD, Indonesia University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 сентября 2020 г.
Первичное завершение (Действительный)
1 января 2022 г.
Завершение исследования (Ожидаемый)
1 июля 2022 г.
Даты регистрации исследования
Первый отправленный
13 февраля 2021 г.
Впервые представлено, что соответствует критериям контроля качества
4 марта 2021 г.
Первый опубликованный (Действительный)
9 марта 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 июня 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 июня 2022 г.
Последняя проверка
1 июня 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 20030379
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .