- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01531816
Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)
Early Rehabilitation in Critically Ill Children, a Pilot Study
연구 개요
상세 설명
In this prospective cohort pilot study, eligible critically ill children aged 3 to 17 years will receive in addition to their usual care, a passive and/or an active mobility intervention, depending on their level of consciousness or cognitive ability. The active intervention will consist of an interactive video game (X Box 360 Kinect), while a cycle ergometer will be used as the passive intervention. The mobility interventions will be applied for a minimum of 10 minutes on day 1, and 20 minutes on day 2. For unconscious patients, or eligible patients who cognitively impaired, the passive intervention will be applied. As soon as the patient is conscious and cooperative, the active intervention will be applied.
The primary outcomes of interest in this pilot study are feasibility (defined as the ability to screen and enroll patients, consent rate and protocol adherence). Secondary outcomes of interest include safety outcomes, clinical outcomes and patient and caregiver satisfaction with the intervention.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- McMaster Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Anticipated PCCU stay of more than 24 hours.
- Clinical stable children at PCCU
- Informed consent and or assent where appropriate
- Agreement of the most responsible PCCU physician
- Age ≥ 3years to < 18 years
Exclusion Criteria:
- Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on stable or weaning doses of vasoactive agents will be considered eligible).
- Anticipated death and/ or withholding of life-sustaining therapies
- The presence of a contraindication to mobilization- e.g. Suspected or actual evidence of cerebral edema or elevated ICP, unstable spinal cord injuries, musculoskeletal injuries/ fixed deformities in the lower limbs (for the use of cycle ergometer) or the upper limbs (for the use of interactive video-gaming)
- Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours).
- Patients who are already mobilizing well/or at their baseline level of function
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single Arm: Study Intervention
Cycle ergometry and/or Interactive video-game
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Feasibility
기간: 2 days
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The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows:
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2 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Safety
기간: Study period
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The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g.
cardiorespiratory events, tube dislodgement's).
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Study period
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Change in activity from baseline
기간: From baseline to end of intervention
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Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
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From baseline to end of intervention
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Caregiver/user perception of intervention
기간: At end of study period
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Self-administered survey of caregiver and or user, to evaluate perceptions of intervention
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At end of study period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen Choong, MB, BCh, MSc, McMaster University
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. .
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