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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07152249
Acronym
ASPIRE-PONV
Enrollment
19480
Registered
2025-09-03
Start date
2025-09-03
Completion date
2026-09-30
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea, Postoperative Vomiting

Keywords

clinical decision support

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.

Interventions

OTHERAW-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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Adult patients: rate of appropriate administration of PONV prophylaxisIntraoperativeFor 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

MeasureTime frameDescription
Adult Patients: incidence of PONV3 hours postoperativelyAdult 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.
Adult Patients: PACU length of stayPACU admission to discharge (usually 1-3 hours post operatively)Duration of time spent in PACU

Countries

United States

Contacts

Primary ContactMiklos Kertai, M.D., Ph.D.
miklos.kertai@vumc.org615-875-0378
Backup ContactGail Mayo
gail.mayo@vumc.org615-936-1705

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026