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Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting 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: NCT02830412
Recruitment Status : Withdrawn (No patients enrolled)
First Posted : July 12, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:

This project intends to develop and implement an electronic reminder for post-operative nausea and vomiting (PONV) prophylaxis into the Anesthesia Record Keeping System.

Each patient will have his or her PONV risk classified based on the following risk factors: Female gender, History of PONV, History of Motion Sickness, Non-smoker and Duration of procedure > 60 minutes.

Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis displayed on the Anesthesia Record Keeping System (ARKS) screen at the beginning of the case.

At the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.

If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.

If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.

The reminder will not recommend a specific medication, intervention or therapy.

It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.

Subjects randomized to not receive the electronic display will have it deactivated.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Other: Postoperative nausea and vomiting (PONV) reminder Not Applicable

Detailed Description:

Each patient will have his or her PONV risk classified based on the following risk factors Female gender, History of PONV or Motion Sickness, Non-smoker and Duration of procedure > 60 min utilizing information already entered into the Anesthesia Record Keeping System. Patients having 0-1 risks factors present will be low risk. 2 risks factors present are medium risk and more than 2 risk factors present are high risk.

Patients will be randomized to either receive the PONV reminder or not. Those receiving the PONV reminder will have the PONV risk assessment and current guideline information for PONV prophylaxis will be displayed on the ARKS screen at the beginning of the case.

In a second step at the end of the procedure (specific at documentation of emergence), the reminder will assess the current status of PONV prophylaxis as per anti-emetic medications administered and compare the current status to the recommended status based on published guidelines.

If the current status is compatible or exceeds the recommended status the reminder will silently document compliance.

If published guidelines suggest additional PONV prophylaxis based on the patients risk profile and a comparison with the currently documented status, an electronic reminder will appear on the ARKS screen to alert the anesthesia provider of an opportunity to enhance guideline adherence.

The reminder will display the PONV risk assessment information, current status of PONV prophylaxis as well as the information that current guidelines recommend additional PONV prophylaxis.

The reminder will not recommend a specific medication, intervention or therapy.

It will be completely the decision of the anesthesia provider if and how to modify the PONV prophylaxis for the patient.

Subjects randomized to not receive the electronic display will have it deactivated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
Actual Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PONV Reminder
After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display
Other: Postoperative nausea and vomiting (PONV) reminder
The postoperative nausea and vomiting (PONV) electronic reminder will be programmed to assess the patient risk for PONV according to the risk factors identified by Apfel and Koivuranta. The PONV risk assessment and current guidelines will be displayed electronically for patients randomized to receive the reminder.

No Intervention: No PONV Reminder
After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display



Primary Outcome Measures :
  1. Incidence of postoperative nausea and vomiting [ Time Frame: 6 hours ]
    Incidence of postoperative nausea and vomiting in the recovery room


Secondary Outcome Measures :
  1. Duration of postoperative anesthesia care unit (PACU) stay [ Time Frame: 6 hours ]
    Time to postoperative anesthesia care unit (PACU) discharge alive (hours)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Procedure with General Anesthesia

Exclusion Criteria:

  • Postoperative admission to the Intensive Care Unit
  • Postoperative fast-track to Phase II
  • Patient remains sedated/intubated at the end of the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830412


Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Saager leif, M.D. The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02830412    
Other Study ID Numbers: 15-1193
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes