Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19,480
- 试验地点
- 1
- 主要终点
- Adult patients: rate of appropriate administration of PONV prophylaxis
研究概览
简要总结
The goal of this prospective, unblinded, pragmatic and repeated crossover trial is to learn if clinical decision support alerts will impact postoperative nausea and vomiting (PONV) prophylaxis and reduce PONV rates in adult patients who have planned surgery with general anesthesia. The main aim is to improve PONV, establishing a scalable Clinical Decision Support (CDS) Tool for personalized PONV prevention.
The primary hypothesis is that, compared with standard care, the Anesthesia Workflow-Driven Clinical Decision Support Tool for Personalized PONV Prevention will be associated with a significant improvement in the rate of appropriate administration of PONV prophylaxis and a significant decrease in the incidence of PONV.
This study will evaluate a new clinical decision support (CDS) tool designed to improve how and when PONV prevention strategies are used. Unlike traditional tools that provide generic, one-time alerts, this new system is integrated into the electronic health record (EHR) and delivers timely, targeted reminders to anesthesia providers at key moments during a patient's surgical care-such as before surgery begins, after anesthesia is given, and before the patient wakes up. These alerts are based on each patient's individual risk for PONV and are intended to support, not replace, clinical judgment. The study will use a crossover design over 12 months, alternating between periods when the tool is active and when it is not. The goal is to determine whether this time-sensitive, workflow-integrated tool can lead to better adherence to best practices and improved patient outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Inclusion Criteria
- •Age ≥ 18 years
- •Planned surgery with general anesthesia with endotracheal intubation or laryngeal mask airway
- •Meet zero or more risk factors for PONV ( history of motion sickness or postoperative nausea and vomiting, non-smoker, female sex, duration of inhalation anesthesia greater than 1 hour, undergoing high risk surgical procedure (cholecystectomy, laparoscopy, gynecologic), and perioperative opioid use)
排除标准
- •ASA 6 including organ procurement,
- •Patients anticipated to be transferred directly to the intensive care unit intubated,
- •Procedure types:
- •Electroconvulsive therapy,
- •Intubation only cases,
- •labor epidurals,
- •transesophageal echocardiography (TEE)/cardioversion,
- •surgery duration < 30 minutes.
- •Operating Room Anaesthesia Provider Inclusion Criteria
- •Any operating room anaesthesia provider of eligible patients will be included.
研究组 & 干预措施
Control
No intervention will be delivered.
Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention
The AW-D CDS Tool will test the delivery of PONV prophylaxis with the use of the clinical decision support tool. When a patient meets the study study criteria, the AW-D CDS Tool will provide automated notification through the electronic health system.
The automated notifications be triggered and linked to the point-of-care/desired time of PONV medication administration throughout the workflow of the anesthetic case to optimize the timing of PONV medication administration (pre-procedure evaluation, post-induction, pre-emergence).
The provider is not forced to follow the recommendations, rather it serves as a reminder of best practices as defined by our department.
The intervention will be assessed using a repeated cross-over design at the institutional level with periods of time for washout, control and study intervention.
干预措施: AW-D Clinical Decision Support Tool (Other)
结局指标
主要结局
Adult patients: rate of appropriate administration of PONV prophylaxis
时间窗: Intraoperative
For adult patients (PONV-5), the rate of appropriate administration of PONV prophylaxis based consensus guidelines and standardized institutional protocols. For the definition of the primary outcome we will be using the definition set by the Michigan PeriOperative Group ASPIRE Program, as follows: adult patients with PONV-05, "are ≥18 years old who had a procedure requiring general anesthesia or cesarean delivery and administered appropriate prophylaxis for PONV"
Adult patients: rate of appropriate administration of PONV prophylaxis
时间窗: Intraoperative
For adult patients (PONV-5), the rate of appropriate administration of PONV prophylaxis based consensus guidelines and standardized institutional protocols. For the definition of the primary outcome we will be using the definition set by the Michigan PeriOperative Group ASPIRE Program, as follows: adult patients with PONV-05, "are ≥18 years old who had a procedure requiring general anesthesia or cesarean delivery and administered appropriate prophylaxis for PONV"
次要结局
- Adult Patients: incidence of PONV(3 hours postoperatively)
- Adult Patients: PACU length of stay(PACU admission to discharge (usually 1-3 hours post operatively))
- Adult Patients: incidence of PONV(3 hours postoperatively)
- Adult Patients: PACU length of stay(PACU admission to discharge (usually 1-3 hours post operatively))
研究者
Miklos Kertai
Professor Cardiothoracic Anesthesiology, Vice Chair Perioperative Medicine, Director Perioperative Precision Medicine Program
Vanderbilt University Medical Center