Accuracy of the SpO2 measurements by the viQtor pulse oximetry compared to matched SaO2 measurements obtained during a hypoxic measurement in healthy volunteers Not Applicable
Conditions
Interventions
The first visit or screening will include medical history and physical examination to determine suitability and determine the presence of inclusion and exclusion criteria. The second visit, the day of
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 dose and 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 5.1. body temperature, between 35.5°C and 37.5°C 5.2. systolic blood pressure, 90 to 150 mmHg 5.3. diastolic blood pressure, 40 to 95 mmHg 5.4. pulse rate, 40 to 100 bpm
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ARMS of SaO2 and SpO2 from paired samples obtained during hypoxia where SpO2 70-100% is measured by reference pulse oximeter. In accordance with FDA guidelines: “In premarket desaturation studies, the primary performance metric is ARMS, the root mean square of the difference between simultaneous paired measurements of SpO2 and SaO2 pooled across all measurements from all subjects.” | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint when a steady plateau in saturation is reached during hypoxia: 1. Bias and ARMS for Fitzpatrick type I-II, type III-IV and V-VI measured using the Bland Altman method 2. Bias and ARMS for gender measured using the Bland Altman method 3. The rate of occult hypoxemia (SaO2 = 88% while SpO2 = 92%) for Fitzpatrick skin type I-II, III-IV and V-VI for ViQtor pulse oximetry 4. The occurrence of occult hypoxemia for the ViQtor, Masimo Radical-7 and Philips Intellivue pulse oximetry 5. The accuracy of viQtor respiratory rate compared to capnography-verified respiratory rate from a reference device (Masimo ISA OR+) 6. The accuracy of the viQtor pulse rate compared to ECG-based heart rate from a reference device (Philips MX-850) 7. Cardiac output effect on the hypoxic ventilatory response measured using the Edwards Hemosphere | — |
Countries
Netherlands
Contacts
Public ContactSimone Jansen
Outcome results
None listed