Hypoxemia occult hypoxemia
Conditions
Interventions
Hypoxia is induced to by administering a FiO2 of 0.06 to induce desaturation to
SpO2 70% measured by a reference pulse-oximeter.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| - Determine whether there is a difference in ARMS obtained for the Fitzpatrick type III-VI to previously obtained measurements for Fitzpatrick type I-II. - Determine if the rate of occult hypoxemia (SaO2 = 92%) differs significantly between Fitzpatrick skin type I-II vs III-VI for the ViQtor. - Determine whether there is a difference in the occurrence of occult hypoxemia for the SmartQare ViQtor, Masimo Radical-7 and Philips Intellivue. - Determine accuracy of ViQtor respiratory rate by comparing it to capnography verified respiratory rate from a reference device (Masimo ISA OR+). - Determine accuracy of ViQtor pulse rate by comparing it to ECG verified heartrate from a reference device (Philips MX-850). - Determine whether changes in cardiac output affect the hypoxic ventilatory response. | — |
Countries
Netherlands
Outcome results
None listed