Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Sedation and Ventilator Weaning Protocol in PICU

9. juni 2022 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indonesien
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesien, 10430
        • Cipto Mangunkusumo hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

  • PICU admission due to post cardiac and respiratory arrest

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Sedation and ventilator weaning protocol
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
Ingen indgriben: Control
  1. Informed consent
  2. Randomization into groups
  3. Sedation and ventilator weaning according to attending physicians
  4. Pain scores and SBS score is noted every 6 hours for the first 24 hours, and every day for the next 24 hours until extubation.
  5. Attending physicians assessed that subject could be weaned: pain scores, SBS score, WAT-1 score
  6. Extubation. Researcher did not take part in the judgement of extubation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reintubation frequency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indonesia University

Efterforskere

  • Ledende efterforsker: Antonius H. Pudjiadi, MD, PhD, Indonesia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2020

Primær færdiggørelse (Faktiske)

1. januar 2022

Studieafslutning (Forventet)

1. juli 2022

Datoer for studieregistrering

Først indsendt

13. februar 2021

Først indsendt, der opfyldte QC-kriterier

4. marts 2021

Først opslået (Faktiske)

9. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2022

Sidst verificeret

1. juni 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 20030379

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sedation

Kliniske forsøg med Sedation and ventilator weaning protocol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner