Health Condition 1: Z008- Encounter for other general examination
Conditions
Interventions
Intervention1: Primary device under test DOX SpO2 Module and SpO2 Sensor Actual device: Patient monitor with DOX SpO2 Module: Each subject will undergo a series of standardized test scenarios where
Sponsors
Criticare Technologies Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults greater or equal to 22 years 2 Pediatric less than 22 years Neonates from birth through the first 28 days of life Infants 29 days to less than 2 years Children 2 years to less than 12 years Adolescents aged 12 through 21 years up to but not including 22 years 3 Informed consent from adult participants or guardians for minors 4 Representation across Monk Skin Tone classification scale.
Exclusion criteria
Exclusion criteria: 1 Poor peripheral perfusion due to underlying disease. 2 Current use of vasoactive drugs. 3 Inability to tolerate sensor placement or procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Overall accuracy of SpO2 sensor will be compared with a validated reference pulse oximeter across adult, pediatric and neonatal subjects. 2.SpO2 measurements under normoxia - Accuracy of SpO2 readings under normoxic condition 3. Effect of skin tone - Evaluation of sensor performance (measurement accuracy) across a range of skin tones, assessed using the Monk Skin Tone (MST) scale.Timepoint: Screening prior to enrollment Baseline after informed consent SpO2 recorded at 15 second intervals during normoxia three readings motion phase for 2 minutes and low perfusion phase up to 5 minutes or observational in neonates All assessments performed during a single visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SpO2 sensor performance under motion: - Stability & continuity of SpO2 readings during rhythmic movements (e.g., arm tapping & hand raising). - Comparison of sensor accuracy & signal quality with reference device under motion artifacts. 2. SpO2 sensor performance under low perfusion: - Accuracy of SpO2 readings under reduced perfusion (e.g., cold-induced or vascular restriction via cuff). - Evaluation of signal consistency & comparison to reference pulse oximeter.Timepoint: Screening prior to enrollment Baseline after informed consent SpO2 recorded at 15 second intervals during normoxia three readings motion phase for 2 minutes & low perfusion phase up to 5 minutes or observational in neonates All assessments performed during a single visit | — |
Countries
India
Contacts
Public ContactDr W D Mohan
Sagar Hospitals, Jayanagar, Bengaluru
Outcome results
None listed