Sedation and Ventilator Weaning Protocol in PICU
9. Juni 2022 aktualisiert von: 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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Tatsächlich)
50
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesien, 10430
- Cipto Mangunkusumo Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Monat bis 17 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria:
- PICU admission due to post cardiac and respiratory arrest
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Kein Eingriff: Control
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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COMFORT score hour 0
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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
Zeitfenster: 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.
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COMFORT score day 1 until extubation
Zeitfenster: 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.
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COMFORT score extubation day
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Reintubation frequency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Antonius H. Pudjiadi, MD, PhD, Indonesia University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. September 2020
Primärer Abschluss (Tatsächlich)
1. Januar 2022
Studienabschluss (Voraussichtlich)
1. Juli 2022
Studienanmeldedaten
Zuerst eingereicht
13. Februar 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. März 2021
Zuerst gepostet (Tatsächlich)
9. März 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Juni 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2022
Zuletzt verifiziert
1. Juni 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 20030379
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