Impact of Oximetry on Hospitalization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Hospitalization for bronchiolitis
研究概览
简要总结
To determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute bronchiolitis
- •Age 4 weeks to 12 months
- •Baseline Respiratory Disease Assessment Instrument (RDAI) ≥ 3 points
- •Informed consent
- •Availability of a telephone
排除标准
- •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
结局指标
主要结局
Hospitalization for bronchiolitis
时间窗: 72 hours from start of study
次要结局
- Proportion of the ED staff/fellows in "strong agreement" or "agreement" with discharge(0, 60, 120, 180, 240, 300, and 360 minutes)
- The proportions of infants receiving supplemental oxygen in the ED(72 hours from start the study)
- Length of stay in the ED (from the time of arrival to the disposition decision)(Determined by outcome measure)
- Proportions of infants with unscheduled medical visits for bronchiolitis symptoms to any medical facility(72 hours from start of study.)
研究者
Suzanne Schuh
Staff Physician
The Hospital for Sick Children