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Sedation and Ventilator Weaning Protocol in PICU

2022년 6월 9일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (실제)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 인도네시아
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, 인도네시아, 10430
        • Cipto Mangunkusumo Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1개월 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patient who need mechanical ventilation for more than 12 hours

Exclusion Criteria:

  • PICU admission due to post cardiac and respiratory arrest

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: Sedation and ventilator weaning protocol
Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Face, Leg, Activity, Cry, Consolability (FLACC) score hour 0
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Reintubation frequency
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Indonesia University

수사관

  • 수석 연구원: Antonius H. Pudjiadi, MD, PhD, Indonesia University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 9월 1일

기본 완료 (실제)

2022년 1월 1일

연구 완료 (예상)

2022년 7월 1일

연구 등록 날짜

최초 제출

2021년 2월 13일

QC 기준을 충족하는 최초 제출

2021년 3월 4일

처음 게시됨 (실제)

2021년 3월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 6월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 6월 9일

마지막으로 확인됨

2022년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 20030379

개별 참가자 데이터(IPD) 계획

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