Noninvasive Hemoglobin Monitor in the ER

Hemoglobin Clinical Trial

— SpHb  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02421250
• Other study ID #: IRB15-0167
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemoglobin

Intervention

Device:
• Radical-7 Noninvasive Hgb Monitor

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to disposition	Measured in minutes	During intervention period (8 weeks)
Other	Time to blood transfusion	Measured in minutes	During intervention period (8 weeks)
Other	Hemodynamics	i.e. blood pressure, heart rate, oxygen saturation, and respiratory rate	During intervention period (8 weeks)
Other	Triage chief complaint	Reason for visiting the ER	During intervention period (8 weeks)
Other	Final physician diagnosis		During intervention period (8 weeks)
Primary	Hemoglobin Measurements	Hemoglobin level to be measured once at triage; hgb measurements (g/dL)	During intervention period (8 weeks)
Secondary	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)