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

NCT05961137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-07-27

No results posted yet for this study

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

  • Sepsis
  • Emergency Medical Services
  • Quality Improvement
  • Shock, Septic
  • Fluid Therapy

Interventions

OTHER

Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol

Modified 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.

OTHER

Conventional Prehospital Suspected Sepsis Protocol

Conventional 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.

Sponsors & Collaborators

  • 410 Medical

    collaborator INDUSTRY

  • Orange Park Medical Center

    lead OTHER

Principal Investigators

  • Martin P Wegman, MD, PhD · Orange Park Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-31
Completion
2022-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961137 on ClinicalTrials.gov