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Testing Dozeeâ??s Contactless Vital Sign Measurements

Clinical Validation of Dozeeâ??s Contactless Vital Sign Measurements - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/08/071959
Enrollment
500
Registered
2024-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: NIL: NIL Control Intervention1: ICU Monitors: Each patient in the ICU connected to ABP or NiBP will be subjected to study which last approximately 24-72 hours Control Intervention2: NIL

Sponsors

Turtle Shell Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consenting adults 18 to 99 years ICU patients They or legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent For NcBP Patients already on radial ABP line or whose BP is measured using cuff BP For RR Patients on continuous capnography monitoring For HR patients on continuous ECG monitoring Patients who have been screened for HR RR and or NcBP can be included for the data collection of SpO2 temperature and NiBP data.

Exclusion criteria

Exclusion criteria: Currently pregnant Exhibit injuries deformities or other abnormalities that in the opinion of the investigator, may prevent proper placement of accessories Level of agitation or non-compliance too high to enroll Needs the use of equipments whose operation can interfere with Dozee signal A significant medical condition in the judgment of the investigator which may compromise the study testing procedures

Design outcomes

Primary

MeasureTime frame
Mean Absolute Error (MAE) of Dozee NcBP across the range of each vitals in comparison to gold standardTimepoint: At baseline

Secondary

MeasureTime frame
MAE of Dozee RR in comparison to gold standard MAE of Dozee HR in comparison to gold standard MAE of Dozee NcBP RR and HR in comparison to gold standard across different comorbidities MAE of Dozee CE or and FDA approved contact based accessories Bland-Altman analysis of the Dozee NcBP RR and HR in comparison to gold standard Deming Regression analysis and Pearson coefficient of the Dozee NcBP RR and HR in comparison to gold standardTimepoint: Baseline

Countries

India

Contacts

Public ContactDr Kumar Chokalingam

Turtle Shell Technologies Pvt Ltd

kumar.chokalingam@dozee.io9008349922

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026