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临床试验/NCT05692453
NCT05692453撤回不适用

Pulse Oximetry Accuracy by Skin Color

Brittany Willer1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
540
试验地点
1
主要终点
Accuracy of Pulse Oximetry

研究概览

简要总结

This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.

详细描述

This is a prospective, non-randomized, non-blinded comparative study.

There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.

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
2 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.

排除标准

  • Patients with cyanotic congenital heart disease.
  • Patients with bleeding disorders.
  • Patients taking blood thinners.

结局指标

主要结局

Accuracy of Pulse Oximetry

时间窗: Baseline

Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations measured by arterial blood gas with co-oximetry (ABG-CoOx).

次要结局

未报告次要终点

研究者

发起方
Brittany Willer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brittany Willer

Director of Quality Improvement & Safety

Nationwide Children's Hospital

研究点 (1)

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