Sedation and Ventilator Weaning Protocol in PICU
9 giugno 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
50
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 mese a 17 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Patient who need mechanical ventilation for more than 12 hours
Exclusion Criteria:
- PICU admission due to post cardiac and respiratory arrest
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Control
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reintubation frequency
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Antonius H. Pudjiadi, MD, PhD, Indonesia University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 settembre 2020
Completamento primario (Effettivo)
1 gennaio 2022
Completamento dello studio (Anticipato)
1 luglio 2022
Date di iscrizione allo studio
Primo inviato
13 febbraio 2021
Primo inviato che soddisfa i criteri di controllo qualità
4 marzo 2021
Primo Inserito (Effettivo)
9 marzo 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 giugno 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2022
Ultimo verificato
1 giugno 2022
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 20030379
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sedation and ventilator weaning protocol
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I.M. Sechenov First Moscow State Medical UniversityCompletatoSedazione profonda | Sedazione moderataFederazione Russa