Impact of Melanin Content on Pulse Oximetry Accuracy - IMPCA

eids Universitair Medisch Centrum0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1.Healthy subjects aged 18 years and older.
•2.Fitzpatrick skin type I-VI.
•3.Subjects must be willing to give written informed consent for the trial and
•able to adhere to visit schedule.
•4. Have no clinical or electrocardiographic signs of ischemic heart disease as
•determined by the Investigator with normal cardiac intervals appropriate for
•their gender. The Screening 12 lead ECG conduction intervals must be within
•gender specific normal range (e.g., QTcF <= 430 msec, PR interval <= 220 msec).
•ECGs are to be judged by the investigator or sub investigator as per
•standardized procedures.
•5. Vital sign measurements must be within the following ranges: (Individuals
•with values outside (or indicate lower or higher) of these ranges may be
•enrolled if clinically acceptable to the investigator and sponsor.
•body temperature, between 35.5°C and 37.5°C
•systolic blood pressure, 90 to 150 mmHg
•diastolic blood pressure, 40 to 95 mmHg
•pulse rate, 40 to 100 bpm

•1.Medical condition that would place the participant at risk during the hypoxic
•measurement or would interfere with the validity of measurements obtained as
•judged by the investigator
•2.Pregnant or lactating
•3.Abnormal Allen*s test (contra-indication arterial catheter placement)
•4.Significant skin abnormalities on the upper arm (psoriasis, eczema, tattoos,
•scarring) that possibly interfere with photoplethysmography
•5.Personal or familial history of cardiac arrhythmias (interfere with
•photoplethysmography)
•6.Significant pulmonary disease which places the subject at increased risk
•during the hypoxic measurements
•7.Use of anti-coagulants for any reason
•8.Excessive facial hair preventing sealing of the occlusive face mask.
•9. Participants who, in the opinion of the investigator, will not be able to
•participate optimally in the study.
•10.Participants who are part of the study staff personnel or family members of
•the study staff personnel

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