Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Postoperative Vomiting; Postoperative Nausea

Treatments: Other: AW-D Clinical Decision Support Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07152249

250773

Details and patient eligibility

About

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.

Enrollment: 19,480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Adult Exclusion Criteria

• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19,480 participants in 2 patient groups

Control

No Intervention group

Description:

No intervention will be delivered.

Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention

Experimental group

Description:

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.

Treatment:

Other: AW-D Clinical Decision Support Tool