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HemoglobinSpHbNCT02421250

Noninvasive Hemoglobin Monitor in the ER

A study testing Radical-7 Noninvasive Hgb Monitor in people with Hemoglobin, run by University of Chicago at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Hemoglobin
What is being tested?
Radical-7 Noninvasive Hgb Monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago

    Chicago, Illinois, 60615

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions
Hemoglobin
Being tested
Radical-7 Noninvasive Hgb Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical-7 Noninvasive Hgb MonitorDevice

Study groups in NCT02421250
Study groupRoleWhat they receive
Radical-7 Non-invasive Hgb MonitorExperimentalWe 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.
Receives: Device: Radical-7 Noninvasive Hgb Monitor
ControlNo interventionWe will use standard-of-care for control group and not use the SpHb monitor.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin Measurements

    Hemoglobin level to be measured once at triage; hgb measurements (g/dL)

    Measured: During intervention period (8 weeks)

Secondary outcomes (1)
  1. Time to procedure

    Measured in minutes; i.e. procedure via operating room, endoscopy with interventional gastroenterology, interventional pulmonology, or ENT, or interventional radiology

    Measured: During intervention period (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Why it stopped: PI terminated the study prior to enrolling any participants.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02421250
Sponsor's protocol ID
IRB15-0167
Acronym
SpHb
Status last verified
Aug 2018
First submitted
15 Apr 2015
Last updated
27 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Radical-7 Noninvasive Hgb Monitor in people with Hemoglobin, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin Measurements (time frame: During intervention period (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.

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