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临床试验/NCT05690269
NCT05690269已完成不适用

Impact of Skin Pigmentation on Accuracy of Pulse Oximetry

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2023年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
1
主要终点
Difference between SpO2 and the SaO2 value in all studied oximeters

研究概览

简要总结

Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation.

This study aims to evaluate different FDA approved pulse oximeters (Nonin co-pilot, massimo Radical 7, Philips-standard of care monitor, innovo premium iP900BP, nellcor PM1000N, Nano100) with SaO2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.

详细描述

The oximeters that will be evaluated are nonin co-pilot, massimo Radical 7, Philips (standard care), Innovo Premium iP900BP, nellcor PM1000N and USA medical supply Nano100. The sensors used will be reusable digital sensors for all oximeters. Oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. Due to the impact of the fingers used for SpO2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. Measurements will be made when the SpO2 with the usual oximeter is <97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. A set of measures that will include all the oximeters tested will be used. Once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. Then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the ICU. While the clinician takes the arterial blood gas, a picture will be simultaneously taken of the SpO2 readings shown by each oximeter, in addition to taking vital signs, O2 flow or FiO2.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • ≥ 18 years old
  • Patients admitted to the Intensive Care Unit
  • Patient has arterial line

排除标准

  • No signal with the oximeter
  • Missing digits preventing application of all probes simultaneously
  • No requirement for arterial blood gases
  • Pigmented nails, fake nails, or nail polish
  • Methemoglobinemia
  • Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19)

结局指标

主要结局

Difference between SpO2 and the SaO2 value in all studied oximeters

时间窗: At the time of arterial blood samples collection. Approximately 15 minutes.

Difference between oximeter SpO2 and the corresponding SaO2 value

次要结局

  • Evaluation of oximeter accuracy in subpopulations of subjects with hypothermia(At the time of arterial blood samples collection. Approximately 15 minutes.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Gomaa

Assistant Professor

University of Cincinnati

研究点 (1)

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