PACU Length of StayNCT03712891
Evaluation of Providing Coffee to Patients Postoperatively to Decrease Length of Stay in the PACU
A study testing Coffee in people with PACU Length of Stay and Postoperative Nausea, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine if providing coffee to patients who self-identify as coffee drinkers postoperatively will decrease the length of stay in the post-anesthesia care unit (PACU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PACU Length of Stay, Postoperative Nausea, Postoperative Vomiting
- What is being tested?
- Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Admitted to Bethesda North Minimally Invasive Surgery Center
- Reports to consume at least one cup of coffee a day for at least 5 days in a week
Who cannot join
- History of PONV
- Pre-existing cardiac arrhythmias
- History of seizure disorder
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine if providing coffee to patients who self-identify as coffee drinkers postoperatively will decrease the length of stay in the post-anesthesia care unit (PACU).
Read the detailed description
Decreasing the length of stay in PACU for surgical patient is a pertinent outcome. The shorter length of stay can achieve higher patient engagement scores, while simultaneously increasing the productivity of the unit. This is achieved by making more beds available for new patients coming from the operating room (OR). One thought was that coffee would benefit the investigator's patients experience through a number of pathways. Initially, the stimulant effect of coffee would create a more alert patient. A more alert patient is more likely to comprehend home care instruction and be ready for discharge earlier. Coffee is often used as a remedy for morning sickness. Ideally the act of drinking coffee or even smelling the coffee may decrease the occurrence of Post-Operative Nausea and Vomiting (PONV) in investigator's patient population. Finally, patients frequently state that the inability to drink their morning coffee is often more difficult than not being able to eat prior to surgery. By allowing those to drink coffee in PACU this would make the patient feel that they are being cared for on an emotional level, in addition to a physical level.
- Being tested
- Coffee
- Keywords
- PACU length of stay, coffee
- Medical subject headings
- Postoperative Nausea and Vomiting, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
Patients will receive coffee in a Styrofoam cup at a temperature of 125 degree Fahrenheit or less. Coffee will be offered to the patient in the PACU once the patient's gag reflex has been restored following their procedure. Volume of estimated coffee consumption will be measured using a sample scale (with a maximum of 300mL of coffee offered)
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving coffee postoperatively | Experimental | Patients who self-identify as coffee drinkers and receive coffee postoperatively Receives: Dietary Supplement: Coffee |
| Patients not receiving coffee postoperatively | No intervention | Patients who self-identify as coffee drinkers and do not receive coffee postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Length of Stay
Post-anesthesia Care Unit length of stay
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 posted19 Oct 2018
- Study start25 Oct 2018
- Primary completion1 Jul 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PACU Length of StayStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Baker, TriHealth Inc.
- Investigators
- Brandon Ballhaus, BSN, RN, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712891
- Sponsor's protocol ID
- 18-050
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2018
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Providing Coffee to Patients Postoperatively to Decrease Length of Stay in the PACU
- ClinicalTrials.gov ID
- NCT03712891
- Acronym / sponsor ID
- 18-050
- Keywords
- PACU length of stay, coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if providing coffee to patients who self-identify as coffee drinkers postoperatively will decrease the length of stay in the post-anesthesia care unit (PACU).
Detailed description
Decreasing the length of stay in PACU for surgical patient is a pertinent outcome. The shorter length of stay can achieve higher patient engagement scores, while simultaneously increasing the productivity of the unit. This is achieved by making more beds available for new patients coming from the operating room (OR). One thought was that coffee would benefit the investigator's patients experience through a number of pathways. Initially, the stimulant effect of coffee would create a more alert patient. A more alert patient is more likely to comprehend home care instruction and be ready for discharge earlier. Coffee is often used as a remedy for morning sickness. Ideally the act of drinking coffee or even smelling the coffee may decrease the occurrence of Post-Operative Nausea and Vomiting (PONV) in investigator's patient population. Finally, patients frequently state that the inability to drink their morning coffee is often more difficult than not being able to eat prior to surgery. By allowing those to drink coffee in PACU this would make the patient feel that they are being cared for on an emotional level, in addition to a physical level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving coffee postoperatively | Experimental | Dietary Supplement: CoffeePatients who self-identify as coffee drinkers and receive coffee postoperatively |
| Patients not receiving coffee postoperatively | No intervention | –Patients who self-identify as coffee drinkers and do not receive coffee postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older
- Admitted to Bethesda North Minimally Invasive Surgery Center
- Reports to consume at least one cup of coffee a day for at least 5 days in a week
Key exclusion criteria (4 listed)
- History of PONV
- Pre-existing cardiac arrhythmias
- History of seizure disorder
- Pregnant
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 |
|---|---|---|
| CoffeePatients will receive coffee in a Styrofoam cup at a temperature of 125 degree Fahrenheit or less. Coffee will be offered to the patient in the PACU once the patient's gag reflex has been restored following their procedure. Volume of estimated coffee consumption will be measured using a sample scale (with a maximum of 300mL of coffee offered) | Dietary supplement | Patients receiving coffee postoperatively |
Primary outcome
PACU Length of Stay
Time frame: 6 hours
Post-anesthesia Care Unit length of stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for PACU Length of Stay
RecruitingObservational study
Effectiveness of PACU vs HCU Postoperative Care
Hospital Length of Stay, Step up Cases
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.
Brandon Ballhaus, BSN, RN principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee in people with PACU Length of Stay and Postoperative Nausea, run by TriHealth Inc. at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PACU Length of Stay (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 13 Dec 2024.