The primary objective is to evaluate the accuracy of the SpO2 measurements by the ViQtor compared to matched SaO2 measurements obtained during a hypoxic measurements to obtain the root mean square (ARMS) for a range of skin types defined by…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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 <= 88% while SpO2 >= 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.
Background summary
Racial bias in pulse oximetry has been demonstrated in a number of
retrospective studies. Occult hypoxemia is more prevalent in black patients and
is related to poorer outcome. This is likely owing to the absence of black
participants in diagnostic accuracy tests for pulse oximetry, which has
resulted in the FDA mandating the inclusion of data from participants with dark
skin in all pre-market studies. The inclusion of 15 % of participants with dark
skin is probably insufficient to definitively determine the lack of racial
bias. Equal distribution among the six Fitzpatrick skin tones and performance
with ARMS < 4.0% would allow for definitively determine absence of racial bias.
Study objective
The primary objective is to evaluate the accuracy of the SpO2 measurements by
the ViQtor compared to matched SaO2 measurements obtained during a hypoxic
measurements to obtain the root mean square (ARMS) for a range of skin types
defined by Fitzpatrick type I-VI
Study design
a validation study
Intervention
Hypoxia is induced to by administering a FiO2 of 0.06 to induce desaturation to
SpO2 70% measured by a reference pulse-oximeter.
Study burden and risks
During the experiment oxygen desaturation will be induced by reducing FiO2
which results in desaturation to SpO2 70%. Hypoxia results in an increase in
ventilation and is associated with euphoria, so called *happy hypoxia*, which
is generally considered to be quite a pleasant experience. Additional oxygen
can be administered in case of discomfort due to hyperventilation and will
swiftly resolve any discomfort. The risk of inducing hypoxia is negligible
since the experiments will only be performed in healthy volunteers who are able
to increase cardiac out thereby maintaining adequate oxygenation by maintaining
adequate oxygen flux to the tissues. To obtain arterial blood gasses to obtain
SaO2 an arterial catheter is placed in the radial artery of the non-dominant
arm. The total amount of blood sampled will not exceed 200 ml which will not
any impact on the participant. Furthermore, all subjects are monitored using
state of the art monitoring equipment comparable to that used in the operating
rooms and intensive care units. The participants do not stand to benefit from
participating in the study other than financial compensation for time spent in
our laboratory.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84986.000.23 |