Pulse Oximetry Accuracy by Skin Color
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
- 否
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
Brittany Willer
Director of Quality Improvement & Safety
Nationwide Children's Hospital
