Clinical Trials Directory

Trials / Completed

CompletedNCT05961137

Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Orange Park Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval. The main question\[s\] it aims to answer are: * Does the intervention affect the timeliness of fluid administration? * Does the intervention affect CMS sepsis bundle care measure compliance? * Does the intervention affect processes and outcomes of care? * Are there any adverse effects? Researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.

Conditions

Interventions

TypeNameDescription
OTHERIncorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis ProtocolModified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.
OTHERConventional Prehospital Suspected Sepsis ProtocolConventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.

Timeline

Start date
2021-04-01
Primary completion
2021-12-31
Completion
2022-08-31
First posted
2023-07-27
Last updated
2023-07-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05961137. Inclusion in this directory is not an endorsement.