Working…
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Postoperative Nausea and Vomiting
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
Enrollment 27034
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations
Hide Arm/Group Description No recommendations were provided for PONV prophylaxis. Automated recommendations on PONV prophylaxis provided by email only. Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Period Title: Overall Study
Started [1] 1518 12809 12707
Completed 1518 12809 12707
Not Completed 0 0 0
[1]
Baseline measurement period
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations Total
Hide Arm/Group Description No recommendations were provided for PONV prophylaxis. Automated recommendations on PONV prophylaxis provided by email only. Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email. Total of all reporting groups
Overall Number of Baseline Participants 1518 12809 12707 27034
Hide Baseline Analysis Population Description
This population was analyzed prior to the institution of CDS for PONV prophylaxis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1131
  74.5%
9573
  74.7%
9603
  75.6%
20307
  75.1%
>=65 years
387
  25.5%
3236
  25.3%
3104
  24.4%
6727
  24.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
53  (16.78) 52  (16.73) 51  (17.15) 52  (16.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
Female
813
  53.6%
6550
  51.1%
6212
  48.9%
13575
  50.2%
Male
705
  46.4%
6259
  48.9%
6495
  51.1%
13459
  49.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
American Indian or Alaska Native
3
   0.2%
12
   0.1%
23
   0.2%
38
   0.1%
Asian
11
   0.7%
100
   0.8%
110
   0.9%
221
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
170
  11.2%
1321
  10.3%
1595
  12.6%
3086
  11.4%
White
1279
  84.3%
10823
  84.5%
10498
  82.6%
22600
  83.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
55
   3.6%
553
   4.3%
481
   3.8%
1089
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
1518 12809 12707 27034
History of PONV/Motion Sickness  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
226
  14.9%
2303
  18.0%
10728
  84.4%
13257
  49.0%
Smoking Status is Current Non Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1518 participants 12809 participants 12707 participants 27034 participants
1183
  77.9%
9723
  75.9%
9352
  73.6%
20258
  74.9%
1.Primary Outcome
Title Adherence to PONV Guidelines
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations
Hide Arm/Group Description:
No recommendations were provided for PONV prophylaxis.
Automated recommendations on PONV prophylaxis provided by email only.
Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Overall Number of Participants Analyzed 1518 12809 12707
Measure Type: Count of Participants
Unit of Measure: Participants
666
  43.9%
5260
  41.1%
5863
  46.1%
2.Secondary Outcome
Title PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
Hide Description The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.
Time Frame PACU recovery period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations
Hide Arm/Group Description:
No recommendations were provided for PONV prophylaxis.
Automated recommendations on PONV prophylaxis provided by email only.
Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Overall Number of Participants Analyzed 1518 12809 12707
Measure Type: Count of Participants
Unit of Measure: Participants
139
   9.2%
1323
  10.3%
1343
  10.6%
3.Secondary Outcome
Title The Number of Prophylactic Interventions for PONV
Hide Description the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations
Hide Arm/Group Description:
No recommendations were provided for PONV prophylaxis.
Automated recommendations on PONV prophylaxis provided by email only.
Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Overall Number of Participants Analyzed 1518 12809 12707
Mean (Standard Deviation)
Unit of Measure: prophylactic antiemetics administered
2.196  (0.932) 2.176  (0.988) 2.129  (0.977)
4.Secondary Outcome
Title Time to Discharge From the Postanesthesia Care Unit (PACU)
Hide Description This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days
Time Frame A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Measurement CDS Email Recommendations CDS Email + Real TIme Recommenations
Hide Arm/Group Description:
No recommendations were provided for PONV prophylaxis.
Automated recommendations on PONV prophylaxis provided by email only.
Number of interventions for PONV prophylaxis were provided both by real-time clinical decision support and via email.
Overall Number of Participants Analyzed 1518 12809 12707
Mean (Standard Deviation)
Unit of Measure: minutes
266  (374) 264  (371) 266  (361)
Time Frame We analyzed adverse events in this patient population during their intraoperative course from entry into OR until exit from the OR (adverse events sourced from our adverse event reporting system), and during their hospitalization (source for mortality data), an average of 4.9 days.
Adverse Event Reporting Description We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
 
Arm/Group Title PONV Clinical Decision Support System
Hide Arm/Group Description

Automated recommendations on PONV prophylaxis provided to anesthesia providers through the anesthesia information management system and email.

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)

Preoperative recommendations: by email: A recommendation on PONV prophylaxis to anesthesia providers through email.

All-Cause Mortality
PONV Clinical Decision Support System
Affected / at Risk (%)
Total   90/27034 (0.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
PONV Clinical Decision Support System
Affected / at Risk (%) # Events
Total   90/27034 (0.33%)    
Investigations   
Mortality - Baseline   7/1518 (0.46%)  7
Mortality - CDS Email Recommendations   43/12809 (0.34%)  43
Mortality - CDS Email + Real Time Recommendations   40/12707 (0.31%)  40
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PONV Clinical Decision Support System
Affected / at Risk (%) # Events
Total   0/27034 (0.00%)    
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Wanderer
Organization: Vanderbilt University Medical Center
Phone: 615-536-5194
EMail: jon.wanderer@vanderbilt.edu
Layout table for additonal information
Responsible Party: Jonathan Wanderer, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02625181     History of Changes
Other Study ID Numbers: 151750
First Submitted: November 12, 2015
First Posted: December 9, 2015
Results First Submitted: October 30, 2018
Results First Posted: March 7, 2019
Last Update Posted: March 7, 2019