Intraoperative Electronic Reminder Module to Enhance Post... | NCT02830412

Studies
Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis

NCT02830412

Sponsor

The Cleveland Clinic

Status

Withdrawn

Last Update Posted

Aug 11, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Postoperative Nausea and Vomiting

Interventions

Postoperative nausea and vomiting (PONV) reminder

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 5, 2015

First Submission Date that Met QC Criteria

Jul 11, 2016

First Posted Date

Jul 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PONV Reminder	Experimental	After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display	Other: Postoperative nausea and vomiting (PONV) reminder
No PONV Reminder	No Intervention	After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Postoperative nausea and vomiting (PONV) reminder	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting in the recovery room	6 hours

Secondary Outcomes

Measure	Description	Time Frame
Duration of postoperative anesthesia care unit (PACU) stay	Time to postoperative anesthesia care unit (PACU) discharge alive (hours)	6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saager leif, M.D.	The Cleveland Clinic	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided