Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 643
- 试验地点
- 1
- 主要终点
- Incidence of Significant Pain in PACU
研究概览
简要总结
The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators hypothesize quality of PACU outcomes will correlate with preoperative demographic and behavioral characteristics as well as intraoperative and anesthetic procedures/techniques. This study will help the investigators improve post anesthetic care quality and create a higher level of satisfaction for patients, family, and health care providers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries:
- •Genito-Urinary/Urology Department:
- •Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents.
- •Otolaryngology Department:
- •Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.
- •Orthopaedics Department:
- •Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.
- •Plastic Surgery Department: Alveolar Cleft Repair.
排除标准
- •English as a second language.
- •< 6 months, > 21 or 30 (hip patients only).
- •Resident of a residential facility or ward of state.
- •Guardianship status unclear.
- •Not headed to the PACU post-operatively.
- •Day of: Projected to arrive in PACU after 3 PM.
- •Duration of surgery well beyond ordinary for procedure type.
- •Exceptionally complex medical history.
结局指标
主要结局
Incidence of Significant Pain in PACU
时间窗: On day of surgery.
Incidence of significant pain defined by pain behavior information from the Faces-Legs-Activity-Cry-Consolability (FLACC) scale, Wong-Baker Faces scale, visual analog scale/numerical scale or adapted numerical rating scale - equal to or more than 5 on a scale from 0 to 10 at any time during the PACU stay.
Incidence of Agitation in PACU
时间窗: On day of surgery.
Incidence of agitation using emergence agitation categorization with Pediatric Agitation Emergence Delirium (PAED) scale equal to or more than 10 on this scale for more than 30 seconds during the recovery period.
Incidence of Post-Operative Nausea or Vomiting
时间窗: On day of surgery.
Post-operative vomiting (POV) will be measured by episodes of vomiting or retching in PACU. This will be a binary outcome - either vomiting/retching occurred or it did not.
次要结局
- Satisfaction of Patients and Families with Post-Operative Care(At two days and two weeks after surgery.)
- Post-Hospitalization Behavior Changes(At two days and two weeks after surgery.)
研究者
Joseph P. Cravero
Department of Anesthesiology, Senior Associate
Boston Children's Hospital