Postoperative NauseaASPIRE-PONVNCT07152249
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
A study testing AW-D Clinical Decision Support Tool in people with Postoperative Nausea and Postoperative Vomiting, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea, Postoperative Vomiting
- What is being tested?
- AW-D Clinical Decision Support Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,480 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
- Conditions
- Postoperative Nausea, Postoperative Vomiting
- Being tested
- AW-D Clinical Decision Support Tool
- Keywords
- clinical decision support
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AW-D Clinical Decision Support ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention will be delivered. |
| Anesthesia Workflow-Driven Clinical Decision Support (AW-D CDS) Tool Intervention | Experimental | 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. Receives: Other: AW-D Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult patients: rate of appropriate administration of PONV prophylaxis
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"
Measured: Intraoperative
Secondary outcomes (2)
Adult Patients: incidence of PONV
Adult 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.
Measured: 3 hours postoperatively
Adult Patients: PACU length of stay
Duration of time spent in PACU
Measured: PACU admission to discharge (usually 1-3 hours post operatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start3 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative NauseaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 19,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Kertai, Vanderbilt University Medical Center
- Investigators
- Miklos Kertai, M.D., Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152249
- Sponsor's protocol ID
- 250773
- Acronym
- ASPIRE-PONV
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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-2025-113842.
PubMed 41667172