NCT03712891

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

October 17, 2018

Results QC Date

November 24, 2023

Last Update Submit

October 29, 2024

Conditions

Keywords

PACU length of staycoffee

Outcome Measures

Primary Outcomes (1)

  • PACU Length of Stay

    Post-anesthesia Care Unit length of stay

    6 hours

Study Arms (2)

Patients receiving coffee postoperatively

EXPERIMENTAL

Patients who self-identify as coffee drinkers and receive coffee postoperatively

Dietary Supplement: Coffee

Patients not receiving coffee postoperatively

NO INTERVENTION

Patients who self-identify as coffee drinkers and do not receive coffee postoperatively

Interventions

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)

Patients receiving coffee postoperatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of PONV
  • Pre-existing cardiac arrhythmias
  • History of seizure disorder
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingPatient Satisfaction

Interventions

Coffee

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Nurse Researcher
Organization
TriHealth

Study Officials

  • Brandon Ballhaus, BSN, RN

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Researcher

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

October 25, 2018

Primary Completion

July 1, 2023

Study Completion

August 16, 2023

Last Updated

December 13, 2024

Results First Posted

December 13, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations