Postoperative Nausea and VomitingNCT02830412
Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis
A study testing Postoperative nausea and vomiting (PONV) reminder in people with Postoperative Nausea and Vomiting, run by The Cleveland Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Postoperative nausea and vomiting (PONV) reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Procedure with General Anesthesia
Who cannot join
- Postoperative admission to the Intensive Care Unit
- Postoperative fast-track to Phase II
- Patient remains sedated/intubated at the end of the procedure
About this study
Official title: A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
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.
Read more
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Postoperative nausea and vomiting (PONV) reminder
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative nausea and vomiting (PONV) reminderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PONV Reminder | Experimental | After patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting in the recovery room
Measured: 6 hours
Secondary outcomes (1)
Duration of postoperative anesthesia care unit (PACU) stay
Time to postoperative anesthesia care unit (PACU) discharge alive (hours)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saager leif, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830412
- Sponsor's protocol ID
- 15-1193
- Status last verified
- Aug 2017
- First submitted
- 5 Oct 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Evaluation of an Intraoperative Electronic Reminder Module to Enhance Postoperative Nausea and Vomiting Prophylaxis Guideline Adherence
- ClinicalTrials.gov ID
- NCT02830412
- Acronym / sponsor ID
- 15-1193
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PONV Reminder | Experimental | Other: Postoperative nausea and vomiting (PONV) reminderAfter patient has non-cardiac surgery, the subject will have Post-Operative Nausea and Vomiting Reminder display |
| No PONV Reminder | No intervention | –After patient has non-cardiac surgery, the subject will not have Post-Operative Nausea and Vomiting Reminder display |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Procedure with General Anesthesia
Key exclusion criteria (3 listed)
- Postoperative admission to the Intensive Care Unit
- Postoperative fast-track to Phase II
- Patient remains sedated/intubated at the end of the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative nausea and vomiting (PONV) reminderThe 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. | Other | PONV Reminder |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: 6 hours
Incidence of postoperative nausea and vomiting in the recovery room
1 secondary outcome
Duration of postoperative anesthesia care unit (PACU) stay
Time frame: 6 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: No
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saager leif, M.D. principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative nausea and vomiting (PONV) reminder in people with Postoperative Nausea and Vomiting, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.