None listed
Conditions
Interventions
Gold Standard:SaO2 measurement value of ABL90FLEX (CO oximeter) instrument blood gas analyzer
Index test:Pulse Saturation Accuracy of Pulse Oximeters
Sponsors
SHENZHEN UNIVERSITY GENERAL HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged between 18 and 50 years (male and female, including dark, medium and light skin, should have at least 2 person or 15% people are dark-skinned); 2. Normal or abnormal vital signs, physical examination, 12-lead electrocardiogram, chest X-ray, laboratory examination (including blood routine, urine routine, coagulation function, blood biochemistry and other functions) have no clinical significance; 3. Agree to participate in the study voluntarily and sign the Informed Consent Form; 4. Artery Blood Gas analysis under breathing air: SaO2 > 95%; COHb10g/ dL.
Exclusion criteria
Exclusion criteria: 1.Those who smoked more than 10 cigarettes per day within 3 months before filtering and those could not accept smoking ban after filtering during the test period, or those were exposed to high carbon monoxide environment; 2.Patients with a history of heart and lung diseases; 3.Blood pressure and heart rate cannot be controlled within the normal range (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; Or hypotension: blood pressure below 90/60mmHg; Heart rate 100 BPM); 4.Platelet count < 60 x 10^9/L or patients with blood coagulation disorders; 5.Those who have donated blood in the past six months; 6.Those who have participated in degree verification of pulse blood oxygen saturation (invasive) within one month or clinical trials of other drugs or medical devices within three months; 7.Pregnant or lactating women (pregnancy in this study is defined as positive urine pregnancy test) or those who have a birth plan within the next month (<=30 days); 8.Those that the investigator considers not suitable for this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse Saturation Accuracy of Pulse Oximeters;Accuracy ; | — |
Countries
CHINA
Contacts
Public ContactHan Wei
SHENZHEN UNIVERSITY GENERAL HOSPITAL
Outcome results
None listed