Clinical study to determine accuracy of test device in low blood oxygen level.

Recruitment & Eligibility

Inclusion Criteria

Subject is willing to give written informed consent for participation in the study.
Healthy Male or Female, between 18-45 years of age.
Subject willing to undergo controlled desaturation.
Subject in a general healthy state with no evidence of ongoing medication and ongoing illness that effect the participation into the study.
At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger will be recruited into the study.

Exclusion Criteria

Subject has any deformity at sensor site location 2.
Pregnant women or nursing mothers 3.
Subject has known respiratory condition 4.
Subject has known cardiovascular disease 5.
Subjects with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, haemophilia, current use of blood thinner: prescription or daily use of aspirin.
Subject on psychotropic drugs 7.
Subject with Diabetes 8.
Subject with artificial nails or nail polish 9.
Subject with Raynaudâ€™s disease 10.
Critically ill individuals 11.
Smokers 12.
Subjects with Haemoglobin <9 g/dL- Self reported 13.
Subjects with carboxyhemoglobin levels larger than 3% 15.
The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Self-reported health conditions as identified in the Health Assessment Form (self-reported), diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy.
Subject participating in any other clinical trial or have had participated in any clinical trial within last 3 months or is on a follow up for any clinical trial.

Primary Outcome Measures

Name	Time	Method
The values obtained from the test device will be compared by the test values obtained by the co-oximeter and statistical analysis will be done as per the EVS-EN ISO 80601-2-61:2011.	same day

Secondary Outcome Measures

Name	Time	Method
Ease of use of test device will be determined as per the list of questionnaires.	same day

Locations (1): Sanjivani Super speciality hospital
🇮🇳
Ahmadabad, GUJARAT, India
Sanjivani Super speciality hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Gaurav H Chhaya
Principal investigator
9825324056
gaurav.chhaya2010@yahoo.com