RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-03
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07152249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Miklos Kertai, M.D., Ph.D.
CONTACT
615-875-0378
miklos.kertai@vumc.org
Gail Mayo
CONTACT
615-936-1705
gail.mayo@vumc.org

Principal Investigator

Miklos Kertai, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Miklos Kertai, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-09-03
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • clinical decision support

Additional Relevant MeSH Terms

  • Postoperative Nausea
  • Postoperative Vomiting