Noninvasive Hemoglobin Monitor in the ER (SpHb)

Comparison of Accuracy and Clinical Outcomes of a Continuous Noninvasive Hemoglobin Monitor in the Emergency Room Setting

The study is a clinical trial to determine whether more efficient medical and operational outcomes can be achieved with using the new SpHb monitoring during triage in the emergency room setting. The investigators also evaluate the accuracy of the measurements of the SpHb device by Maximo versus the gold standard of central hospital laboratory value. In addition, the investigators will assess patient satisfaction with the tool.

Study Overview

• Status: Withdrawn
• Conditions: Hemoglobin
• Intervention / Treatment: Device: Radical-7 Noninvasive Hgb Monitor

Detailed Description

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60615
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria: The following is the inclusion criteria for each participant based on initial complaints in triage of bleeding:

• GI bleeding-melena, hematochezia, hematemesis
• Vaginal bleeding
• Epistaxis
• Hematuria
• Hemoptysis
• Sickle cell patients
• Bleeding from recent surgical procedure
• Dizziness or lightheadedness in LVAD patients or hematology and oncology patients (i.e. cancer, leukemia, lymphoma-currently receiving chemo, stem cell treatment, or bone marrow transplant).

Exclusion Criteria:

• Exclusion criteria would consist of those patients in critically ill condition i.e. trauma, those needing massive transfusion protocol, cardiac arrest with active CPR, active seizure, hypothermia, acute intoxication/AMS that prohibits cooperation or following commands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radical-7 Non-invasive Hgb Monitor; We use the Radical-7 Noninvasive Hgb Monitor device (provided by Masimo Corporation from Irvine USA) to measure hemoglobin levels in patients in the experimental group.	Device: Radical-7 Noninvasive Hgb Monitor
No Intervention: Control; We will use standard-of-care for control group and not use the SpHb monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Measurements	Hemoglobin level to be measured once at triage; hgb measurements (g/dL)	During intervention period (8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to procedure	Measured in minutes; i.e. procedure via operating room, endoscopy with interventional gastroenterology, interventional pulmonology, or ENT, or interventional radiology	During intervention period (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to disposition	Measured in minutes	During intervention period (8 weeks)
Time to blood transfusion	Measured in minutes	During intervention period (8 weeks)
Hemodynamics	i.e. blood pressure, heart rate, oxygen saturation, and respiratory rate	During intervention period (8 weeks)
Triage chief complaint	Reason for visiting the ER	During intervention period (8 weeks)
Final physician diagnosis		During intervention period (8 weeks)

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Thomas Spiegel, MD MBA, University of Chicago

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB15-0167