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A clinical trial for evaluating safety and effectiveness of continuous monitoring with hemodynamic monitor

A clinical trial for evaluating safety and effectiveness of continuous monitoring with hemodynamic monitor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093733
Enrollment
Unknown
Registered
2024-12-11
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

None

Interventions

Gold Standard:The control device was a portable color Doppler ultrasound system (model specification: M9, registration certificate number: National Machinery Note 20193061691) of Shenzhen Mindray Biom
Index test:Suzhou Sensus Medical Technology Co., Ltd. Name of test device: hemodynamic monitor
Model specifications: ROSC-A1/ROSC-A2/ROSC-A3/ROSC-B1/ROSC-B2/ROSC-S1/ROSC-S2

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Continuous monitoring of hemodynamic parameters, age 18 years and above, gender not specified; 2. The subjects and/or their guardians must understand the purpose of the study, demonstrate sufficient adherence to the study protocol, and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. In the stage of unstable or rapid progression of disease, frequent medical intervention may be necessary; 2. Syndrome involving systemic infection or uncontrolled probe skin contamination or breach of probe skin contact site, or other important organ failure; 3. Pregnant or lactating women; 4. Women who have participated in other pharmaceutical or medical device clinical trials within the first month prior to screening; 5. Other circumstances where investigators believe that the subject should not participate in this clinical trial for the benefit of the subject.

Design outcomes

Primary

MeasureTime frame
The accuracy of blood hemodynamics monitoring;

Secondary

MeasureTime frame
Monitoring parameter consistency (Bland–Altman consistency analysis);

Countries

China

Contacts

Public ContactTao Ying

Shanghai Sixth People's Hospital

yingtaomail@yeah.net+86 189 3017 3491

Outcome results

None listed

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