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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea; Postoperative Vomiting
• Intervention / Treatment: Other: AW-D Clinical Decision Support Tool

• Study Type: Interventional
• Enrollment (Estimated): 19480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gail Mayo; Phone Number: 615-936-1705; Email: gail.mayo@vumc.org
• Study Contact Backup: Name: Miklos Kertai, M.D., Ph.D.; Phone Number: 615-875-0378; Email: miklos.kertai@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Miklos Kertai, MD; Email: miklos.kertai@vumc.org
      • Contact: Ellen Stallings; Email: ellen.stallings@vumc.org
      • Sub-Investigator: Ellen Stallings, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention will be delivered.
Experimental: 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.	Other: AW-D Clinical Decision Support Tool; The AW-D Clinical Decision Support Tool will test the automatic delivery of best practice advisories for antiemetic medications at critical timepoints in the perioperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult patients: rate of appropriate administration of PONV prophylaxis	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"	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Patients: PACU length of stay	Duration of time spent in PACU	PACU admission to discharge (usually 1-3 hours post operatively)
Adult Patients: incidence of PONV	Adult Patients: Incidence of PONV as defined by MPOG ASPIRE: Presence of i) PONV-03b, EHR documented nausea/vomiting in the immediate postoperative period, and/or ii) PONV-03, EHR documented PONV OR rescue antiemetic administration in the immediate postoperative period.	3 hours postoperatively

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Miklos Kertai, M.D., Ph.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 25, 2025
• First Submitted That Met QC Criteria: August 25, 2025
• First Posted (Estimated): September 3, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: clinical decision support
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 250773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No