Impact of Melanin Content on Pulse Oximetry Accuracy

Recruiting

Conditions: Hypoxemia
occult hypoxemia
10024970

Registration Number: NL-OMON56576

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

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 <= 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> the primary performance metric is ARMS, the root mean square of the difference<br /><br>between simultaneous paired measurements of SpO2 and SaO2 pooled across all<br /><br>measurements from all subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Determine whether there is a difference in ARMS obtained for the Fitzpatrick<br /><br>type III-VI to previously obtained measurements for Fitzpatrick type I-II.<br /><br>- Determine if the rate of occult hypoxemia (SaO2 <= 88% while SpO2 >= 92%)<br /><br>differs significantly between Fitzpatrick skin type I-II vs III-VI for the<br /><br>ViQtor.<br /><br>- Determine whether there is a difference in the occurrence of occult hypoxemia<br /><br>for the SmartQare ViQtor, Masimo Radical-7 and Philips Intellivue.<br /><br>- Determine accuracy of ViQtor respiratory rate by comparing it to capnography<br /><br>verified respiratory rate from a reference device (Masimo ISA OR+).<br /><br>- Determine accuracy of ViQtor pulse rate by comparing it to ECG verified<br /><br>heartrate from a reference device (Philips MX-850).<br /><br>- Determine whether changes in cardiac output affect the hypoxic ventilatory<br /><br>response. </p><br>