Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of accuracy in patients
研究概览
简要总结
By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.
详细描述
Objectives:
- To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation.
- To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Inclusion Criteria:
- •Age 18 - 60 years,
- •Non smoker,
- •Good general health and physical fitness
- •Informed Consent
排除标准
- •Current or history of tobacco smoking (> 5 py)
- •Current alcohol or drug abuse
- •Heart disease or untreated arterial hypertension
- •Pulmonary disease
- •Epilepsy or other major neurologic disease
- •Dark skin colour
- •Known anemia
- •Severe metabolic disease (e.g. diabetes)
- •Pregnancy
- •Inclusion Criteria:
- •Age ≥ 18 years
- •Long term oxygen therapy at rest and/or on physical effort
- •Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or < 60 mmHg with PHT or polycythemia (men Hb > 174 g/L, women Hb > 140 g/L) or:
- •Oxygen desaturation on effort (SpO2 < 90%)
- •Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis
- •Informed Consent
- •Exclusion Criteria:
- •Severe hypoxemia (pO2 <40 mmHg)
- •Severe hypercapnia (pCO2 >55 mmHg)
- •Acute respiratory infection or systemic infection,
- •Severe systolic heart disease (LVEF < 25%)
- •Myocardial infarction during the last month before inclusion
- •Unstable angina pectoris
- •Severe aortic stenosis (mean gradient > 40mmHg, valve area <1 cm2)
- •Rhythmogenic heart disease
- •Severe or untreated arterial hypertension (blood pressure > 180mmHg systolic, >100mmHg diastolic)
- •Anemia (Hb < 120 g/l)
- •Known or suspected coagulation disorder (e.g. INR > 4)
- •Severe or untreated metabolic disorder
- •Neurologic disease or dementia
- •Pregnancy
- •History of non-compliance to medical treatment
- •Current alcohol, drug abuse or current tobacco smoking
- •Dark skin color
研究组 & 干预措施
Healthy Subjects and patients
Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.
干预措施: OxyFrame (Device)
结局指标
主要结局
Assessment of accuracy in patients
时间窗: At baseline
Assessment of the accuracy of the novel pulse oximeter sensor in patients qualifying for LTOT over the entire saturation range by calculating accuracy root mean square (ARMS). Continuous SpO2 measurement of the novel pulse oximeter will be compared to measurements assessed by 2 standard pulse oximeters and arterial blood gas analysis.
次要结局
- Assessment of accuracy in healthy volunteers(At baseline)