Sedation and Ventilator Weaning Protocol in PICU
2022年6月9日 更新者：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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
DKI Jakarta
-
Jakarta Pusat、DKI Jakarta、インドネシア、10430
- Cipto Mangunkusumo Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1ヶ月～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria:
- PICU admission due to post cardiac and respiratory arrest
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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介入なし：Control
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
時間枠：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
時間枠：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.
|
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 12
時間枠：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.
|
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 18
時間枠：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.
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Face, Leg, Activity, Cry, Consolability (FLACC) score day 1 until extubation
時間枠：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.
|
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Face, Leg, Activity, Cry, Consolability (FLACC) score extubation day
時間枠：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
時間枠：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
時間枠：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.
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COMFORT score hour 12
時間枠：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.
|
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COMFORT score hour 18
時間枠：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
時間枠：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
時間枠：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.
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Ventilator time
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reintubation frequency
時間枠：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
時間枠：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
時間枠：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
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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
時間枠：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
時間枠：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.
|
The scoring will be noted during hour-1 after sedatives/analgetic administration following intubation.
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Near infrared spectroscopy hour-6
時間枠：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.
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Near infrared spectroscopy hour-12
時間枠：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.
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Inotropic intervention
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Antonius H. Pudjiadi, MD, PhD、Indonesia University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年9月1日
一次修了 (実際)
2022年1月1日
研究の完了 (予想される)
2022年7月1日
試験登録日
最初に提出
2021年2月13日
QC基準を満たした最初の提出物
2021年3月4日
最初の投稿 (実際)
2021年3月9日
学習記録の更新
投稿された最後の更新 (実際)
2022年6月14日
QC基準を満たした最後の更新が送信されました
2022年6月9日
最終確認日
2022年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20030379
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