Impact of Oximetry on Hospitalization in Acute Bronchiolitis
Impact of Oximetry on Hospitalization
연구 개요
상태
정황
상세 설명
This is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. Although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief.
We hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the AAP can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. This study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Acute bronchiolitis
- Age 4 weeks to 12 months
- Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
- Informed consent
- Availability of a telephone
Exclusion Criteria:
- Pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia
- Severe respiratory distress, defined as the retraction component on the RDAI as 8 out of possible 9 points
- True baseline oxygen saturation less than 88% in room air
- Transfers from other institutions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 1
In this arm, patients are monitored with oximeters displaying true saturation values
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Physicians will be presented with real saturations.
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실험적: 2
In this arm, patients are monitored with oximeters with displayed saturations 3 percentage points above true values
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Physicians will be presented with saturation measurements three percentage points above the true values.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Hospitalization for bronchiolitis
기간: 72 hours from start of study
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72 hours from start of study
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The proportions of infants receiving supplemental oxygen in the ED
기간: 72 hours from start the study
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72 hours from start the study
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Length of stay in the ED (from the time of arrival to the disposition decision)
기간: Determined by outcome measure
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Determined by outcome measure
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Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility
기간: 72 hours from start of study.
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72 hours from start of study.
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Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge
기간: 0, 60, 120, 180, 240, 300, and 360 minutes
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0, 60, 120, 180, 240, 300, and 360 minutes
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공동 작업자 및 조사자
간행물 및 유용한 링크
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. .