- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00441506
Effects of Daily Interruption of Sedatives in Critically Ill Children
Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. In adult intensive care unit (ICU) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days. These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects.
It is unknown whether these results can be extrapolated to critically ill children. Moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. Also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives.
It is unknown if daily interruption of sedatives is feasible in critically ill children. The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Gelderland
-
Nijmegen, Gelderland, 네덜란드, 6500HB
- Radboud University Nijmegen Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Intubated and mechanically ventilated for > 24 hours
- Expect further mechanical ventilation for > 48 hours
- Receiving midazolam and morphine for sedation
- Written informed consent given by parents
Exclusion Criteria:
- Inclusion in another trial
- Transfer from an outside institution where sedatives had been administered
- Neuromuscular blockers
- Metabolic disease
- Neuromuscular disease
- Encephalopathy
- Epilepsy
- Pulmonary hypertension
- Neurotrauma
- Raised intracranial pressure
- Life expectancy less than a month/infaust prognosis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
amount of (near) incidents
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
|
total amount of sedatives administered
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
|
time to wake up (after sedation is stopped), comfort scale
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
|
BIS monitoring
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
time on ventilator
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
|
LOS on ICU
기간: Until extubation or 28 days
|
Until extubation or 28 days
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Peter Pickkers, MD, PhD, Radboud University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .