CTRI/2022/03/041270Completed未知
A Single-Center, Prospective, Open Label Clinical Investigational Study to Validate Accuracy of Pulse Oximeters in Measuring the SpO2 as Compared to Arterial Blood Analysis of SaO2 by CO-Oximetry During Non-Motion Conditions
Choicemmed Technology India Pvt Ltd0 sites15 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male and female participants aged equal to or more than 18 years and equal to or less than 50 years at the time of consent.
- •2. Participants who can and are willing to provide Informed Consent.
- •3. Participants who understand and are willing to participate in the clinical study and can comply with CIP requirements.
- •4. Participants that are non-smokers.
- •5. Participants having dark pigmentation (Type IV -VI on Fitzpatrick pigmentation scale)
- •6. Presence of both normal upper limbs.
Exclusion Criteria
- •1. Participants less than 18 years or more than 50 years of age.
- •2.Participants considered as being morbidly obese (defined as BMI more than 39.5).
- •3.Participants with compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study.
- •4.(Note: Certain malformations may still allow to participate if the condition is noted and would not affect the particular sites utilized.)
- •5.Having recent medical tests done that included an injection of dyes, Magnetic resonance imaging (MRI) or Computed Tomography (CT) environment.
- •6.Female participants of childbearing potential having positive UPT at the time of screening.
- •7.Nursing female participants.
- •8.Participants with known respiratory conditions such as: (self-reported/ clinical history)
- •a.Uncontrolled / severe asthma
- •c.Pneumonia / bronchitis
- •d.Shortness of breath / respiratory distress
- •e.Unresolved respiratory or lung surgery with continued indications of health issues
- •f.Emphysema, COPD, lung disease
- •9.Participants with known heart or cardiovascular conditions such as: (self-reported/ clinical history, except for blood pressure and ECG review)
- •a.Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen).
- •b.Have had cardiovascular surgery
- •c.Chest pain (angina)
- •d.Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- •e.Previous heart attack
- •f.Blocked artery
- •g.Unexplained shortness of breath
- •h.Congestive heart failure (CHF)
- •i.History of stroke
- •j.Transient ischemic attack
- •k.Carotid artery disease
- •l.Myocardial ischemia
- •m.Myocardial infarction
- •n.Cardiomyopathy
- •10.Participants with following health conditions (self-reported/ clinical history)
- •b.Uncontrolled thyroid disease
- •c.Kidney disease / chronic renal impairment
- •d.History of seizures (except childhood febrile seizures)
- •f.History of unexplained syncope
- •g.Recent history of frequent migraine headaches
- •h.Recent symptomatic head injury (within the last 2 months)
- •i.Cancer / chemotherapy
- •11.Participants with known clotting disorders (self-reported/ clinical history)
- •a.History of bleeding disorders or personal history of prolonged bleeding from injury
- •b.History of blood clots
- •c.Hemophilia
- •d.Current use of blood thinner: prescription or daily use of aspirin
- •12.Participants with severe contact allergies (self-reported/ clinical history) to standard adhesives, latex or other materials found in pulse oximetry sensors.
- •13.Participants having failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio less than 0.4)
- •14.Participants having unwillingness or inability to remove colored nail polish from test digits/ fingers.
- •15.Participants with any other condition, which as per the investigator would jeopardize the outcome of the trial.
- •16.Participants who are not willing to follow study procedures.
Investigators
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