Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis

NCT02830412 | Withdrawn

• 1 other identifier: 15-1193
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting

  Incidence of postoperative nausea and vomiting in the recovery room

  6 hours

Secondary Outcomes (1)

• Duration of postoperative anesthesia care unit (PACU) stay

  6 hours

Study Arms (2)

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

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.

PONV Reminder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Procedure with General Anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Saager leif, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: July 12, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share