Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
The LifeFlow rapid infusion device is a handheld manually-operated device that has been shown in early trials to increase the rate of bolus fluid infusion up to 3 times the rate of delivery attributed to conventional rapid infusion devices. The device addresses other technical barriers to fluid resuscitation, including reducing complexity and provider fatigue. LifeFlow utilizes standard IV or intraosseous (IO) vascular access devices to quickly and efficiently deliver appropriate volumes of crystalloid fluid to patients during emergent fluid resuscitation. The purpose of this study is to determine if intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current standard techniques in adult patients who present to the Emergency Department with septic shock.
Patients with conditions such as septic shock, anaphylaxis, and hypovolemic shock may require rapid fluid administration to restore blood pressure and tissue perfusion. Newly Updated Surviving Sepsis Campaign (SSC) guidelines call for patients with septic shock to receive a 30ml/kg intravenous (IV) fluid challenge within 1 hour of emergency department (ED) arrival, with improved outcomes shown with early fluid infusion. Patients with shock and severe hypotension may require even more rapid fluid treatment, up to 4ml/kg/min. While excess fluid infusion may be associated with harm, early fluid infusion for the reversal of shock can reduce the need for subsequent interventions, ultimately leading to improved patient outcomes. This may be especially true in patients with hypotension, who are at greater risk of death if not treated quickly, as a single episode of hypotension in patients with sepsis is correlated with a significantly increased risk of death.
In patients who require IV fluid bolus therapy, technical barriers such as slow infusion rates, technically complex infusion devices, and inadequate nursing resources may lead to delay in fluid administration and inadequate resuscitation. As recommended by the SSC guidelines, patients receiving fluid bolus therapy for septic shock require frequent reassessment of clinical response. With current fluid delivery techniques, the ability to reassess quickly and relate fluid administration directly to markers of hemodynamic improvement is limited.
The LifeFlow rapid infusion device is a handheld manually-operated device that has been shown in early trials to increase the rate of bolus fluid infusion up to 3 times the rate of delivery attributed to conventional rapid infusion devices. The device addresses other technical barriers to fluid resuscitation, including reducing complexity and provider fatigue. LifeFlow utilizes standard IV or intraosseous (IO) vascular access devices to quickly and efficiently deliver appropriate volumes of crystalloid fluid to patients during emergent fluid resuscitation.
The purpose of this study is to determine if intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current standard techniques in adult patients who present to the Emergency Department with septic shock.
Primary Hypothesis
Inclusion Criteria:
Adult ED patients ≥ 18 years of age
Patients with hypotension (Systolic Blood Pressure (SBP) < 90) mmHg or Mean Arterial Pressure (MAP) < 65 mmHg) and at least one of the following:
Patients who will be determined by treating emergency physician to receive rapid fluid bolus for hypotension
Patients with adequate cardiac windows
EF is 35% or greater
No increased number of B lines per rib interspace (3 or more) in multiple locations on lung ultrasound
Exclusion Criteria: