Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 9 for:    MECLIZINE

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02625181
Recruitment Status : Completed
First Posted : December 9, 2015
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Wanderer, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE November 12, 2015
First Posted Date  ICMJE December 9, 2015
Results First Submitted Date  ICMJE October 30, 2018
Results First Posted Date  ICMJE March 7, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Adherence to PONV Guidelines [ Time Frame: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case ]
PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support. [ Time Frame: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case, an expected average of 4.5 hours ]
The adherence to PONV guidelines will be used as the primary outcome.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: PACU recovery period ]
    The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.
  • The Number of Prophylactic Interventions for PONV [ Time Frame: 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 ]
    the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.
  • Time to Discharge From the Postanesthesia Care Unit (PACU) [ Time Frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU ]
    This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
  • PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: 24 hours after surgery ]
    The occurrence of PONV within 24 hours after surgery
  • The Number of Prophylactic Interventions for PONV [ Time Frame: 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, an expected average of 4.5 hours ]
    the absolute number of prophylactic interventions applied
  • Time to discharge readiness at the postanesthesia care unit (PACU) [ Time Frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, , an expected average of 4 hours ]
  • Number of times that the hyperlink for additional information is accessed [ Time Frame: A specific time frame on one day before surgery and the day of surgery: from the moment that the preoperative emails are sent to the end of the anesthetic case, up to 36 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
Official Title  ICMJE Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
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.
Detailed Description

Nausea and vomiting after surgery (PONV) is a common side effect of the surgical procedure, general anesthesia and opioid use occurring in about one third of patients. In addition to being very unpleasant for patients, it is associated with longer recovery room stays and increased costs. Much research has been done on prophylactic interventions that may be applied during the surgical procedure to prevent PONV. Current national guidelines recommend that a risk score is used to decide on the number of prophylactic interventions to administer to a patient. Based on specific characteristics of individual patients and the procedures that they are about to undergo, such a risk score predicts the risk of PONV for each individual. According to the national guidelines, patients with higher risks of PONV should receive more prophylactic interventions. However, in a busy operating room where the anesthesia provider performs multiple patient care tasks, closely following the recommendations to minimize the risk of PONV is often difficult.

Computers may help anesthesia providers to adhere to best practices for PONV prevention by providing so-called decision support. A decision support system for PONV automatically calculates the risk of PONV for an individual patient and presents this predicted risk to the anesthesia provider on the computer screen that is being used by the anesthesia team for record keeping. In recent studies, such decision support systems have been demonstrated to improve adherence to PONV guidelines, especially when a recommendation on the number of interventions is added to the predicted risk. However, in these studies there was still quite some room for improvement of the adherence to PONV guidelines. In general, implementation science is only beginning to understand how such decision support systems are best used to improve medical decision making and minimize practice variations among providers. Further study of how the design of decision support systems impacts the decision making of healthcare providers is therefore warranted.

In this proposed study, the investigators will implement several decision support elements for PONV that aim to help anesthesia providers to adhere to the departmental PONV guidelines during the anesthetic case. The study consists of three phases. The first phase is the preintervention phase - i.e. before the decision support has been implemented. The second phase is the first intervention phase with one CDSS feature added. The third phase is the second intervention phase with another CDSS feature added.

The decision support elements will provide information about the patient's predicted risk of PONV and the number of prophylactic interventions that the departmental guidelines recommend based on that risk. We will start with preoperative email notifications, followed by an element within the anesthesia information management system (AIMS) that are displayed around the start and end of the procedure. All forms of decision support only provide recommendations. The anesthesia provider is free to act on the message or ignore the notifications.

The investigators will compare the adherence to PONV guidelines and the actual occurrence of PONV (both nausea and emetic events: vomiting and retching) in the post-anesthesia care unit (PACU) between all study phases and between the different interventions. The goal of the comparison is to evaluate which decision support elements have an added value to optimize guideline adherence for PONV prophylaxis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE
  • Procedure: Automated recommendation at the start of the case
    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)
  • Procedure: Automated notification at the start of surgery
    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.
  • Procedure: Preoperative recommendations: by email
    A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
  • Procedure: Automated notification at the end of surgery
    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.
  • Device: Anesthesia Information Management System (AIMS)
    The anesthesia electronic record keeping system
  • Device: Perioperative Data Warehouse (PDW)
    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.
  • Procedure: General anesthesia
    Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
  • Procedure: Elective surgery
    Surgical procedures that are scheduled and not an emergency.
  • Drug: Propofol
    Anesthetic drug used to maintain general anesthesia
  • Drug: Sevoflurane
    Anesthetic drug used to maintain general anesthesia
  • Drug: Isoflurane
    Anesthetic drug used to maintain general anesthesia
  • Drug: Desflurane
    Anesthetic drug used to maintain general anesthesia
  • Drug: Scopolamine
    Prophylactic antiemetic
  • Drug: Droperidol
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Haloperidol
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Dexamethasone
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Promethazine
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Meclizine
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Aprepitant
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Metoclopramide
    Rescue antiemetic
  • Drug: Fentanyl
    Analgesic drug / Opioid
  • Drug: Sufentanil
    Analgesic drug / Opioid
  • Drug: Alfentanil
    Analgesic drug / Opioid
  • Drug: Remifentanil
    Analgesic drug / Opioid
  • Drug: Morphine
    Analgesic drug / Opioid
  • Drug: Meperidine
    Analgesic drug / Opioid
  • Drug: Hydromorphone
    Analgesic drug / Opioid
  • Drug: Methadone
    Analgesic drug / Opioid
  • Drug: Oxycodone
    Analgesic drug / Opioid
  • Drug: Oxymorphone
    Analgesic drug / Opioid
  • Drug: Hydrocodone
    Analgesic drug / Opioid
  • Drug: Ketamine
    Analgetic / Analgesic drug
  • Drug: Ondansetron
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Granisetron
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Dolasetron mesylate
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Palonosetron
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Tropisetron
    Prophylactic antiemetic & rescue antiemetic
  • Drug: Ramosetron
    Prophylactic antiemetic & rescue antiemetic
Study Arms  ICMJE Experimental: PONV clinical decision support system
Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.
Interventions:
  • Procedure: Automated recommendation at the start of the case
  • Procedure: Automated notification at the start of surgery
  • Procedure: Preoperative recommendations: by email
  • Procedure: Automated notification at the end of surgery
  • Device: Anesthesia Information Management System (AIMS)
  • Device: Perioperative Data Warehouse (PDW)
  • Procedure: General anesthesia
  • Procedure: Elective surgery
  • Drug: Propofol
  • Drug: Sevoflurane
  • Drug: Isoflurane
  • Drug: Desflurane
  • Drug: Scopolamine
  • Drug: Droperidol
  • Drug: Haloperidol
  • Drug: Dexamethasone
  • Drug: Promethazine
  • Drug: Meclizine
  • Drug: Aprepitant
  • Drug: Metoclopramide
  • Drug: Fentanyl
  • Drug: Sufentanil
  • Drug: Alfentanil
  • Drug: Remifentanil
  • Drug: Morphine
  • Drug: Meperidine
  • Drug: Hydromorphone
  • Drug: Methadone
  • Drug: Oxycodone
  • Drug: Oxymorphone
  • Drug: Hydrocodone
  • Drug: Ketamine
  • Drug: Ondansetron
  • Drug: Granisetron
  • Drug: Dolasetron mesylate
  • Drug: Palonosetron
  • Drug: Tropisetron
  • Drug: Ramosetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
27034
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2015)
32000
Actual Study Completion Date  ICMJE November 30, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All adult patients (18 years and older) that are scheduled for an elective surgical procedure under general anesthesia

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02625181
Other Study ID Numbers  ICMJE 151750
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Wanderer, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan P Wanderer, MD, MPhil Vanderbilt University Medical Center, Division of Anesthesiology
PRS Account Vanderbilt University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP