Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
NCT ID: NCT07152249
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13120 participants
INTERVENTIONAL
2025-09-03
2026-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
No intervention will be delivered.
No interventions assigned to this group
Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention
The AW-D CDS Tool will test the delivery of PONV prophylaxis with the use of the clinical decision support tool. When a patient meets the study study criteria, the AW-D CDS Tool will provide automated notification through the electronic health system.
The automated notifications be triggered and linked to the point-of-care/desired time of PONV medication administration throughout the workflow of the anesthetic case to optimize the timing of PONV medication administration (pre-procedure evaluation, post-induction, pre-emergence).
The provider is not forced to follow the recommendations, rather it serves as a reminder of best practices as defined by our department.
The intervention will be assessed using a repeated cross-over design at the institutional level with periods of time for washout, control and study intervention.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Any operating room anaesthesia provider of eligible patients will be included.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Miklos Kertai
Professor Cardiothoracic Anesthesiology, Vice Chair Perioperative Medicine, Director Perioperative Precision Medicine Program
Principal Investigators
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Miklos Kertai, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Miklos Kertai, MD
Role: primary
Ellen Stallings
Role: backup
Other Identifiers
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250773
Identifier Type: -
Identifier Source: org_study_id