406EMF Early Fluid Delivery by Emergency Medical Services for Sepsis Using a Novel Rapid Infusion Device

Abstract

Study ObjectivesEarly fluid resuscitation improves clinical outcomes in patients with sepsis. However, adherence to fluid delivery guidelines is less than optimal, and outcomes for patients with severe sepsis and septic shock remain poor. Emergency medical services (EMS) clinicians are tasked with initiating life-saving measures for sepsis patients, often with varied quality of care and success. Traditional fluid administration methods, including pressure bag and push-pull with manual syringe, are limited in speed of volume delivery and ease of use. We are conducting a comparative effectiveness study of a novel rapid infusion device for out-of-hospital fluid administration in patients with sepsis.MethodsA pre-post observational study design is being used to evaluate a hand-operated, rapid infusion device (LifeFlow® Plus, 410 Medical, Durham, North Carolina) implemented in a single large EMS system in January 2022. The EMS system has an established sepsis patient care protocol with detailed guidance on out-of-hospital sepsis screening, intravenous (IV) fluid therapy, and sepsis alert criteria. Prior to implementation, EMS clinicians completed intensive education and training on device operation through didactics and simulation-based training. Study data on patient demographics, vital signs, medical history, out-of-hospital care, and in-hospital outcomes are extracted from the EMS system electronic health record and existing data linkages with emergency department (ED) and hospital records. Eligible patients include adult and pediatric patients managed and transported by EMS under the sepsis protocol and treated with IV fluid therapy. Patients with a history of congestive heart failure or end stage renal disease on dialysis or otherwise contraindicated to fluid therapy are excluded. To assess device effectiveness, outcomes will be compared between pre- and post-implementation phases (July-December 2021 and February-July 2022, respectively) in an intention-to-treat analysis. The primary outcome is the proportion of eligible patients receiving target fluid volume (ie, at least 500 mL) prior to ED arrival. Secondary outcomes include ED/hospital discharge disposition, hospital length of stay, and in-hospital mortality. The primary outcome will be evaluated with multivariable logistic regression adjusting for potential confounders (eg, patient demographics, out-of-hospital time, and clinical factors). Secondary analyses will include the clinical outcomes, a subgroup of septic shock patients, and an as-treated analysis.ResultsWe project a sample size of 525 patients and 80% power to statistically detect a minimum adjusted odds ratio of 1.7 for the primary outcome, which corresponds to 65% receiving target fluid volume in the post-implementation phase and 52% in the pre-implementation phase. Because this study is in progress, results are not available at this time. Data collection started in July 2021. Data collection and analysis will be completed in August 2022, and final results will be presented at the ACEP22 Research Forum.ConclusionThis study will generate real-world evidence on the effectiveness of novel rapid infusion by EMS to achieve out-of-hospital fluid administration goals and to improve clinical outcomes in patients with sepsis. This research on a novel fluid delivery system will have significant impact on the field of early management of sepsis and has the potential to reduce sepsis-related morbidity and mortality.No, authors do not have interests to disclose Study ObjectivesEarly fluid resuscitation improves clinical outcomes in patients with sepsis. However, adherence to fluid delivery guidelines is less than optimal, and outcomes for patients with severe sepsis and septic shock remain poor. Emergency medical services (EMS) clinicians are tasked with initiating life-saving measures for sepsis patients, often with varied quality of care and success. Traditional fluid administration methods, including pressure bag and push-pull with manual syringe, are limited in speed of volume delivery and ease of use. We are conducting a comparative effectiveness study of a novel rapid infusion device for out-of-hospital fluid administration in patients with sepsis. Early fluid resuscitation improves clinical outcomes in patients with sepsis. However, adherence to fluid delivery guidelines is less than optimal, and outcomes for patients with severe sepsis and septic shock remain poor. Emergency medical services (EMS) clinicians are tasked with initiating life-saving measures for sepsis patients, often with varied quality of care and success. Traditional fluid administration methods, including pressure bag and push-pull with manual syringe, are limited in speed of volume delivery and ease of use. We are conducting a comparative effectiveness study of a novel rapid infusion device for out-of-hospital fluid administration in patients with sepsis. MethodsA pre-post observational study design is being used to evaluate a hand-operated, rapid infusion device (LifeFlow® Plus, 410 Medical, Durham, North Carolina) implemented in a single large EMS system in January 2022. The EMS system has an established sepsis patient care protocol with detailed guidance on out-of-hospital sepsis screening, intravenous (IV) fluid therapy, and sepsis alert criteria. Prior to implementation, EMS clinicians completed intensive education and training on device operation through didactics and simulation-based training. Study data on patient demographics, vital signs, medical history, out-of-hospital care, and in-hospital outcomes are extracted from the EMS system electronic health record and existing data linkages with emergency department (ED) and hospital records. Eligible patients include adult and pediatric patients managed and transported by EMS under the sepsis protocol and treated with IV fluid therapy. Patients with a history of congestive heart failure or end stage renal disease on dialysis or otherwise contraindicated to fluid therapy are excluded. To assess device effectiveness, outcomes will be compared between pre- and post-implementation phases (July-December 2021 and February-July 2022, respectively) in an intention-to-treat analysis. The primary outcome is the proportion of eligible patients receiving target fluid volume (ie, at least 500 mL) prior to ED arrival. Secondary outcomes include ED/hospital discharge disposition, hospital length of stay, and in-hospital mortality. The primary outcome will be evaluated with multivariable logistic regression adjusting for potential confounders (eg, patient demographics, out-of-hospital time, and clinical factors). Secondary analyses will include the clinical outcomes, a subgroup of septic shock patients, and an as-treated analysis. A pre-post observational study design is being used to evaluate a hand-operated, rapid infusion device (LifeFlow® Plus, 410 Medical, Durham, North Carolina) implemented in a single large EMS system in January 2022. The EMS system has an established sepsis patient care protocol with detailed guidance on out-of-hospital sepsis screening, intravenous (IV) fluid therapy, and sepsis alert criteria. Prior to implementation, EMS clinicians completed intensive education and training on device operation through didactics and simulation-based training. Study data on patient demographics, vital signs, medical history, out-of-hospital care, and in-hospital outcomes are extracted from the EMS system electronic health record and existing data linkages with emergency department (ED) and hospital records. Eligible patients include adult and pediatric patients managed and transported by EMS under the sepsis protocol and treated with IV fluid therapy. Patients with a history of congestive heart failure or end stage renal disease on dialysis or otherwise contraindicated to fluid therapy are excluded. To assess device effectiveness, outcomes will be compared between pre- and post-implementation phases (July-December 2021 and February-July 2022, respectively) in an intention-to-treat analysis. The primary outcome is the proportion of eligible patients receiving target fluid volume (ie, at least 500 mL) prior to ED arrival. Secondary outcomes include ED/hospital discharge disposition, hospital length of stay, and in-hospital mortality. The primary outcome will be evaluated with multivariable logistic regression adjusting for potential confounders (eg, patient demographics, out-of-hospital time, and clinical factors). Secondary analyses will include the clinical outcomes, a subgroup of septic shock patients, and an as-treated analysis. ResultsWe project a sample size of 525 patients and 80% power to statistically detect a minimum adjusted odds ratio of 1.7 for the primary outcome, which corresponds to 65% receiving target fluid volume in the post-implementation phase and 52% in the pre-implementation phase. Because this study is in progress, results are not available at this time. Data collection started in July 2021. Data collection and analysis will be completed in August 2022, and final results will be presented at the ACEP22 Research Forum. We project a sample size of 525 patients and 80% power to statistically detect a minimum adjusted odds ratio of 1.7 for the primary outcome, which corresponds to 65% receiving target fluid volume in the post-implementation phase and 52% in the pre-implementation phase. Because this study is in progress, results are not available at this time. Data collection started in July 2021. Data collection and analysis will be completed in August 2022, and final results will be presented at the ACEP22 Research Forum. ConclusionThis study will generate real-world evidence on the effectiveness of novel rapid infusion by EMS to achieve out-of-hospital fluid administration goals and to improve clinical outcomes in patients with sepsis. This research on a novel fluid delivery system will have significant impact on the field of early management of sepsis and has the potential to reduce sepsis-related morbidity and mortality.No, authors do not have interests to disclose This study will generate real-world evidence on the effectiveness of novel rapid infusion by EMS to achieve out-of-hospital fluid administration goals and to improve clinical outcomes in patients with sepsis. This research on a novel fluid delivery system will have significant impact on the field of early management of sepsis and has the potential to reduce sepsis-related morbidity and mortality.