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临床试验/NCT02421250
NCT02421250撤回不适用

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

University of Chicago2 个研究点 分布在 1 个国家开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Hemoglobin Measurements

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

研究组 & 干预措施

Radical-7 Non-invasive Hgb Monitor

Experimental

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.

干预措施: Radical-7 Noninvasive Hgb Monitor (Device)

Control

No Intervention

We will use standard-of-care for control group and not use the SpHb monitor.

结局指标

主要结局

Hemoglobin Measurements

时间窗: During intervention period (8 weeks)

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

次要结局

  • Time to procedure(During intervention period (8 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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