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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Nausea; Postoperative Vomiting

• Registration Number: NCT07152249
• Lead Sponsor: Vanderbilt University Medical Center

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 and pediatric 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study Start: 2025-09-01
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pediatric Patients: rate of appropriate administration of PONV prophylaxis	Intraoperative	For pediatric patients (PONV-4). the rate of appropriate administration of PONV prophylaxis based on 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 (MPOG) ASPIRE Program, as follows: i) pediatric patients with PONV-04: "are patients 3 through 17 years of age, who receive appropriate antiemetic prophylaxis preoperatively and/or intraoperatively"
Adult patients: rate of appropriate administration of PONV prophylaxis	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 Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States