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NCT Number: NCT07152249

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location status: Recruiting

Location contact

Ellen Stallings

CONTACT

[email protected]

Ellen Stallings, MD

SUB_INVESTIGATOR

Miklos Kertai, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Adult patients: rate of appropriate administration of PONV prophylaxis

    Time frame: 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"

Secondary outcomes

  1. Adult Patients: incidence of PONV

    Time frame: 3 hours postoperatively

    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.

  2. Adult Patients: PACU length of stay

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

    Duration of time spent in PACU

Study contacts

Contact information is provided by the study sponsor or research team.

Gail Mayo

CONTACT

[email protected]

615-936-1705

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

CONTACT

[email protected]

615-875-0378

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: ASPIRE-PONV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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