Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT05542732
Eligibility Criteria:
Inclusion Criteria:
1. Healthy non-disabled subjects with American Society of Anesthesiologists health score (ASA) of 1 or 2.
2. The subject is aged ≥18 and ≤ 65 years.
3. The subject is not intellectual disabled, and has provided informed consent and is willing to comply with the study procedures.
Exclusion Criteria:
1. Heavy smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
2. Individuals subject to conditions that result in elevated levels of methemoglobin
3. Individuals with hypoxia (SpO2 \< 95 % at 21 % of oxygen)
4. Severe claustrophobia
5. Subject is known with altitude disease
6. The subject is obese (BMI ≥ 31 kg/m2).
7. The subject has a known history of moderate to severe heart disease, lung disease, kidney or liver disease.
8. The subject is diagnosed with moderate to severe asthma.
9. The subject is known with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, ... who, in the opinion of the investigator, would make them unsuitable for study participation.
10. The subject has any other serious systemic illness.
11. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
12. The subject has a history of fainting or vasovagal response.
13. The subject has a history of sensitivity or allergy to local anesthetics or disinfectants.
14. The subject has a diagnosis of Raynaud's disease.
15. The subject has unacceptable collateral circulation based on exam by the investigator.
16. The subject is pregnant, lactating or trying to get pregnant.
17. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
18. The subject has any other condition, which in the opinion of the investigators would make the subject unsuitable for the study.
19. The subject refuses to remove nail-vanish.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05542732
Study Brief:
Protocol Section:
NCT05542732