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Study to check the accuracy and precision of Real Time Multi Vital Monitoring solution in comparison with standard vital monitoring methods.

Validity of Real Time Multi Vital Monitoring using Remote monitoring Technology: A pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041712
Enrollment
196
Registered
2022-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: Real Time Multi vital monitoring (RTMVM) solution: RTMVM is an artificial intelligence and cloud based technology based solution that continuously records vitals including BP, PR, RR,

Sponsors

Vigo Care PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy Volunteers 1.Healthy, adult male aged 18-45 years, with BMI 18.5- 25kg/m2 2.Subjects of normal health as determined by medical history and physical examination. 3.Subjects with screening lab values within normal limits or considered insignificant by physician / investigator. 4.Should comply with all study procedures Patient: 1.Known CAD patient, stable on treatment. 2.Either gender and aged 18 to 65 years. 3.Should comply with all study procedures

Exclusion criteria

Exclusion criteria: Healthy volunteers 1.History of Contact dermatitis or hypersensitivity to patch material. 2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study 3.Subjects with clinically significant physical disabilities Patients 1.History of Contact dermatitis or hypersensitivity to patch material. 2.Regular smoker and has difficulty abstaining from smoking for 48 hours before study 3.Subjects with clinically significant physical disabilities

Design outcomes

Primary

MeasureTime frame
1.Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in healthy volunteers. Timepoint: 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours respectively.

Secondary

MeasureTime frame
Correlate the vitals including temperature, heart rate, respiratory rate, oxygen saturation, ECG derived from MVM solution and Standard methods in Coronary heart disease patients.Timepoint: 0, 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours receptively.

Countries

India

Contacts

Public ContactDr Sudha Bala

ESIC Medical College and Hospital

mehdialimirza@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026