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

Study acronym: ASPIRE-PONV
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 2026 → Dec 2026
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Record History

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  1. Minor Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary and study completion pushed from Sep 2026 to Dec 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Enrollment target: 13120 to 19480v4
  3. Notable Primary endpoints: 2 to 1
    • Eligibility criteria shortened, about 49 words
    • Secondary endpoints: 4 to 2
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 2025 to Sep 3, 2025
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07152249
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)
Postoperative Nausea, Postoperative Vomiting
Related terms Postoperative Nausea and Vomiting
Enrollment 19,480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov