Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
1 other identifier
interventional
27,034
1 country
1
Brief Summary
The purpose of this study is to determine how automated recommendations are best presented to optimize the adherence to guidelines on prophylaxis for nausea and vomiting after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedResults Posted
Study results publicly available
March 7, 2019
CompletedMarch 7, 2019
March 1, 2019
1.3 years
November 12, 2015
October 30, 2018
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to PONV Guidelines
PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.
A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case
Secondary Outcomes (3)
PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
PACU recovery period
The Number of Prophylactic Interventions for PONV
A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case
Time to Discharge From the Postanesthesia Care Unit (PACU)
A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU
Study Arms (1)
PONV clinical decision support system
EXPERIMENTALAutomated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
Interventions
The first notification is the main notification that informs the anesthesia providers at the start of anesthesia of the risk score for that individual patient and the recommended number of prophylactic interventions. The notification occurs within the anesthesia information management system (AIMS)
The second notification within the AIMS will notify the anesthesia providers at the start of surgery when no prophylaxis has been given while three or more interventions were recommended.
A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
A notification will remind anesthesia providers at the closing of surgery how many prophylactic interventions are required to adhere to the recommended number of interventions.
The anesthesia electronic record keeping system
The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the preoperative emails.
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Surgical procedures that are scheduled and not an emergency.
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Anesthetic drug used to maintain general anesthesia
Prophylactic antiemetic \& rescue antiemetic
Eligibility Criteria
You may qualify if:
- All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia
You may not qualify if:
- Patients undergoing emergency surgery or organ transplantation
- Patients that are transferred directly to the Intensive Care Unit after the end of the procedure
- Patients that die intraoperatively
- Procedures that only require a sedative level of anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We were unable to complete analysis of hyperlink data for PONV recommendations as planned because the data were not archived as intended. We were unable to include University of Washington as a collaborative site due to technical differences.
Results Point of Contact
- Title
- Jonathan Wanderer
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan P Wanderer, MD, MPhil
Vanderbilt University Medical Center, Division of Anesthesiology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director of Procedure Preparation Center
Study Record Dates
First Submitted
November 12, 2015
First Posted
December 9, 2015
Study Start
July 1, 2016
Primary Completion
November 2, 2017
Study Completion
November 30, 2017
Last Updated
March 7, 2019
Results First Posted
March 7, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share