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Clinical trial of BeneVision N12 patient monitor combined with non-contact respiration module for monitoring respiration rate in neonates

Clinical trial of BeneVision N12 patient monitor combined with non-contact respiration module for monitoring respiration rate in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077892
Enrollment
Unknown
Registered
2023-11-23
Start date
2023-11-24
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Subjects were selected as neonates requiring respiratory monitoring

Interventions

Gold Standard: The gold standard for respiratory rate monitoring is end-breath CO2 monitoring
Index test:The index test for respiratory rate monitoring was performed using the BeneVision N12 patient monitor with a non-contact respiration module

Sponsors

Guangdong Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.1 Years

Inclusion criteria

Inclusion criteria: (1) need to monitor etCO2, newborn within 28 days of birth, gender is not limited; (2)The legal guardian must understand the clinical trial, voluntarily participate in it and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Subjects with unstable conditions requiring frequent medical intervention; (2) persons determined by the clinician not to be suitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Accuracy of Respiratory rate;Mean Bias of Respiratory rate ;—

Countries

China

Contacts

Public ContactChuan Nie

Guangdong Women and Children Hospital

chuannie@sina.com+86 136 8227 0294

Outcome results

None listed

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