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Recruiting NCT07152249

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

No phase Interventional Postoperative Nausea Postoperative Vomiting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AW-D Clinical Decision Support Tool.
Who it may be relevant to
Registry conditions: Postoperative Nausea, Postoperative Vomiting. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other AW-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.

Primary outcome measures

  • Adult patients: rate of appropriate administration of PONV prophylaxis [Time frame: Intraoperative]
Secondary outcome measures (2)
  • Adult Patients: incidence of PONV [Time frame: 3 hours postoperatively]
  • Adult Patients: PACU length of stay [Time frame: PACU admission to discharge (usually 1-3 hours post operatively)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Publications

  • 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 PMID 41667172

Identifiers

NCT: NCT07152249 · 250773

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗