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

NCT07152249 | Recruiting DMC

• 1 other identifier: 250773
• Study Type: interventional
• Target: 19,480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea; Postoperative Vomiting

Keywords

clinical decision support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adult Patients: incidence of PONV

  3 hours postoperatively

• Adult Patients: PACU length of stay

  PACU admission to discharge (usually 1-3 hours post operatively)

Study Arms (2)

Control

NO INTERVENTION

No intervention will be delivered.

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

EXPERIMENTAL

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

Interventions

AW-D Clinical Decision Support Tool OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Any operating room anaesthesia provider of eligible patients will be included.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Related Publications (1)

• Stallings EG, Wanderer JP, Balavage M, Henson CP, Fowler L, Eden S, Shotwell MS, Gruss C, Neuhafen KR, Gelfand BJ, Kertai MD; ASPIRE-PONV Investigators. Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial. BMJ Open. 2026 Feb 10;16(2):e113842. doi: 10.1136/bmjopen-2025-113842.

  PMID: 41667172 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Miklos Kertai, M.D., Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miklos Kertai, M.D., Ph.D.

CONTACT

615-875-0378; miklos.kertai@vumc.org

Gail Mayo

CONTACT

615-936-1705; gail.mayo@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Cardiothoracic Anesthesiology, Vice Chair Perioperative Medicine, Director Perioperative Precision Medicine Program

Model Details: This trial will use a repeated crossover design. The planned 12-month period of enrollment will be divided into four 12 -week blocks (10 weeks of control or intervention followed by a 2-week washout period).

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)