SpHbComparison of Accuracy and Clinical Outcomes of a Continuous Noninvasive Hemoglobin Monitor in the Emergency Room Setting
Radical-7 Noninvasive Hgb Monitor
Services Research Study
Summary
Study start date: June 1, 2015
Actual date on which the first participant was enrolled.A major issue faced by emergency departments all over the world is overcrowding, resulting from limited resources (i.e. staff, space, equipment) attending to a large of patients that exceeds the physical and/or staffing capacity of the ED. To manage the issue of overcrowding, the system of triage was created to help prioritize each patient's case, based on set criteria to determine time to treatment and/or which treatment is indicated. Our study will contribute to the discovery of more efficient ways of triaging patients based on objective and subjective criteria for decision-making about treatment and disposition, while simultaneously maintaining patient safety. The investigators achieve this aim by evaluating the efficiency of a noninvasive and continuous total hemoglobin (SpHb) monitor provided by Masimo Corporation (Irvine USA). Standard hemoglobin measurements via central laboratory testing are invasive, painful, time-consuming, have increased lag time for analysis, potentially expose health care workers to blood-borne illness, and delay treatment onset because they require direct blood sampling. The new SpHb monitor potentially offers a new way to evaluate objective criteria about patients to maximize treatment outcomes and appropriate dispositions. The SpHb monitor has the potential to trend hemoglobin monitoring, quicken the detection of acute anemia, and avoid the complications, anxiety, expense, and patient discomfort associated with invasive blood draws. In the ED setting, there is a need to efficiently triage a patient and designate a disposition for appropriate treatment management and outcomes. Hemoglobin level is an accurate indicator that helps distinguish patients who need early blood transfusion and meet criteria for admission. Noninvasive technology, such as the SpHb device by Masimo, will assist with common goals in emergency medicine: to efficiently and accurately decrease wait times to treatment and disposition, screening patients who have difficult venous access, providing repeated sampling without causing iatrogenic blood loss linked to anemia, and offering an approach that may be used to develop an organized coherent therapeutic plan based on physiologic criteria for the emergency patient as he/she proceeds from the ED to the OR, the hospital general floor, and the ICU. This study will be performed at the University of Chicago Medical Center in the main adult emergency room. Patients will be examined and enrolled into our study initially by the triage nurse after each person has given his/her written informed consent. Randomization process will be carried out based on days of the week. Patients will be enrolled in one group every two days. For example, starting on the week when we begin the trial, we will assign Monday patients to the control group, Tuesday patients to the experimental group, Wednesday patients to the control group… Two groups are similar in characteristics. Depending on whether the subject has been randomized into the control or experimental group, we will not use or use the SpHb monitor to obtain measurements. To obtain measurements, we place the probe of the device on the patient's finger and record the hemoglobin level determined by the Masimo Radical-7 Pulse CO-Oximeter. We will collect patient satisfaction data 2 minutes after the placement of the SpHb device and 2 minutes after the blood sampling. The collection of blood is considered standard of care. Along with recording hemoglobin measurements, we will record triage chief complaint, final physician diagnosis, time to blood products transfusion, time to disposition (i.e. discharge home or Hospital admission via intensive care unit or general floor), time to procedure (i.e. procedure via operating room, endoscopy with interventional gastroenterology, interventional pulmonology, or ENT, or interventional radiology), and hemodynamics (i.e. blood pressure, heart rate, oxygen saturation, and respiratory rate).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location