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Performance Evaluation of Lifepath-C in measuring respiratory rate during stable and motion condition with respect to gold standard.

Performance Evaluation of Lifepath-C as an adjunct monitoring device in measuring respiratory rate during ambulatory and non-ambulatory conditions against physician scored end tidal CO2.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022993
Enrollment
15
Registered
2020-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R069- Unspecified abnormalities of breathing

Interventions

Intervention1: LifePath-C: LifePath-C is a compact, portable, wireless physiological vital signs monitoring device. LifePath-C (LPC) is designed to enable healthcare professionals to continuously coll

Sponsors

Elastic Care Inc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Male or female aged 21-60 years and above 2. Subjects willing to sign written informed consent document and ready to comply with the study procedure 3. Subjects with RR 12-40 BPM

Exclusion criteria

Exclusion criteria: 1. Subjects requiring attended, in-hospital monitoring for life-threatening diseases. 2. Subjects with any active implantable devices. 3. Subjects during pregnancy. 4. Subjects with broken or fragile skin on the torso 5. Subjects who are allergic to acrylic, hydro gel, or silicone adhesives 6. Uncooperative or unconscious subject 7. Subject not capable to speak or communicate 8. Subjects with chronic diseases or are under medication for the same 9. Subjects with any significant respiratory disease. 10. Subjects on CNS depressants or stimulant

Design outcomes

Primary

MeasureTime frame
The results of the test device will be evaluated against physician scored CO2from reference device for each evaluable pair and will be analyzed for acceptable tolerance of±3 BPM or 10% of readings, whichever is greaterTimepoint: same day—

Secondary

MeasureTime frame
1.Usability questionnaire. 2. Incidence of any safety related issues with the test device 3.Difference in results obtained by Capnostream35 RR and Physician scored RR obtained through Co2 waveform from Capnostream35 4. Difference in results obtained by Capnostream35 RR and test device RR output 5. Difference in results obtained during artifacts obtained by Co2 waveform from Capnostream35, Capnostream 35 RR output and test device RR output Timepoint: same day—

Countries

India

Contacts

Public ContactSubham Dutta

Netpulse Services

arpan.khagram@pathcom.com9561855162

Outcome results

None listed

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