Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Average Richmond Agitation Sedation Scale (RASS) compared between the two groups
研究概览
简要总结
This study is being conducted to evaluate the safety and efficacy of weighted blankets to reduce agitation in patients in the post-procedural phase after cardiac catheterization and electrophysiology procedures in the post anesthesia care unit.
The study hypothesizes that compared to the traditional and current post-procedural strategy, weighted blanket use will reduce agitation and therefore lessen the need for additional sedation along with a reduction of post-procedure vascular complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac catheterization or electrophysiology procedure
- •Post Procedure bedrest plan for greater than (>)2 hours
- •Duration of recovery planned for 11th floor cardiac PACU
排除标准
- •Patients less than (<) 40 pounds (18 kilogram (kg))
- •Patients > 220 pounds (100 kg)
- •Recovery anticipated to not be in our cardiac PACU
- •Posttraumatic stress disorder
- •Claustrophobia
- •Uncontrolled seizure disorders
- •Open heart surgery within 30 days
- •Severe pulmonary hypertension
- •Severe asthma
- •Sleep apnea requiring continuous positive airway pressure (CPAP)
- •Known diaphragm paresis
- •Home vent/CPAP
- •Restrictive lung disease (such as patients with scoliosis)
- •Higher risk for upper respiratory airway occlusion (such as patients with Down Syndrome)
- •Cast, brace or splint, fractures
- •Degenerative muscular disorder (such as patients with cerebral palsy)
- •Areas of impaired skin integrity
- •Gastrostomy tube
- •Percutaneous endoscopic gastrostomy
- •Tracheostomy
- •Chest tube(s)
- •PACU procedures required (within 1 hour post arrival): post operative (post op) echocardiogram, post op Xray, post op electrocardiogram
结局指标
主要结局
Average Richmond Agitation Sedation Scale (RASS) compared between the two groups
时间窗: up to 60 minutes (after arrived to PACU)
Richmond Agitation Sedation Score is a validated and standardized scoring system ranging from negative 5 (unarousable sedation) to 0 (awake and calm) to 4 (combative).
次要结局
- Safety measures assessed by vital sign parameters for respiratory effort(up to 6 hours after arriving in the PACU)
- Analgesia administered in the recovery area(up to 6 hours after arriving in the PACU)
- Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation)(up to 6 hours after arriving in the PACU)
- Safety measures assessed by vital sign parameters for respiration rate(up to 6 hours after arriving in the PACU)
- Incidence of vascular complications in the recovery area(up to 6 hours after arriving in the PACU)
研究者
Brian J Armstrong
Registered nurse and principal investigator
University of Michigan