Improving prevention of nausea and vomiting after surgery
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
This trial will test whether an electronic clinical decision support alert helps anesthesia teams give the right medicines to prevent nausea and vomiting in adults having planned surgery with general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07152249 on ClinicalTrials.gov |
What this trial studies
This is a prospective, unblinded, pragmatic repeated-crossover trial that embeds a workflow-driven clinical decision support (CDS) tool into the electronic health record to guide personalized PONV prophylaxis. Adult patients having planned surgery with general anesthesia and an endotracheal tube or laryngeal mask airway are included unless they meet specified exclusions such as very short procedures or planned ICU transfer. The trial compares periods with the CDS alerts active to periods of standard care, measuring appropriate administration of PONV prophylaxis and subsequent PONV rates. The intervention is designed to be scalable and to change real-world clinician behavior rather than relying on extra research procedures.
Who should consider this trial
Good fit: Adults aged 18 or older having planned surgery under general anesthesia with endotracheal intubation or a laryngeal mask airway who do not meet exclusion criteria are eligible.
Not a fit: Patients expected to go directly to the ICU intubated, ASA 6/organ procurement cases, very short procedures (<30 minutes), or excluded procedure types (e.g., electroconvulsive therapy, intubation-only cases) are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the tool could increase appropriate use of PONV prevention and lower rates of postoperative nausea and vomiting for surgical patients.
How similar studies have performed: Previous clinical decision support systems have improved guideline-based perioperative care in some settings, but an EHR-integrated, repeated-crossover CDS specifically targeting personalized PONV prevention is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Miklos Kertai, M.D., Ph.D. — Vanderbilt University Medical Center
- Study coordinator: Miklos Kertai, M.D., Ph.D.
- Email: miklos.kertai@vumc.org
- Phone: 615-875-0378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.