Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Total sleep time
研究概览
简要总结
Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.
详细描述
Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
- •Age 1-18 years
- •Pediatric Early Warning Score ≤ 1 at 2000
- •A parent/home caregiver present to consent to study
- •Patient and home caregiver speak English or Spanish.
- •Deemed appropriate for forgone overnight vital signs by care team (attending MD/Advanced Practice Provider and bedside RN).
排除标准
- •Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
- •Patients requiring O2 monitoring at home.
- •The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
- •Anaphylaxis within 24 hours
- •Within the first 24 hours post-operative period
- •Requiring oxygen above baseline
- •Fever in the last 24 hours.
- •Sepsis alert in the last 72 hours.
结局指标
主要结局
Total sleep time
时间窗: From enrollment to end of treatment at 24 hours
Measured by actigraphy
次要结局
- Restfulness upon waking(From enrollment to the end of treatment at 24 hours)
- Nocturnal wake frequency(From enrollment to the end of treatment at 24 hours)
- Nocturnal wake duration(From enrollment to the end of treatment at 24 hours)
- Total sleep time(From enrollment to the end of treatment at 24 hours)
- Overnight disruptions(From enrollment to the end of treatment at 24 hours)
- Sleep disturbances(From enrollment to the end of treatment at 24 hours)