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A prospective, open, multi-center study on the effectiveness and safety of the PresCCO monitoring function of the iV12 patient monitor

A prospective, open, multi-center study on the effectiveness and safety of the PresCCO monitoring function of the iV12 patient monitor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109880
Enrollment
Unknown
Registered
2025-09-26
Start date
2024-03-25
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Suitable for invasive continuous cardiac output (CCO) monitoring of patients

Interventions

Testing Equipment Group:Hemodynamic monitoring
Control apparatus group:Conventional instruments

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to No maximum

Inclusion criteria

Inclusion criteria: 1:Agree to participate in this study and sign the informed consent form; 2: Age >= 2 years old; 3: Those who have undergone PiCCO monitoring, or those who require hemodynamic monitoring such as assessment of volume status, cardiac function, vascular tone, and extravascular lung water, including but not limited to: Acute Respiratory Distress Syndrome (ARDS), shock, sepsis, heart failure, severe infection, severe pancreatitis, severe burns, and perioperative period of major surgery.

Exclusion criteria

Exclusion criteria: 1: Patients with a current or past medical history documenting intracardiac shunt, tricuspid insufficiency, aortic insufficiency, aortic stenosis, aneurysm, severe pneumothorax or extensive peripheral arterial occlusive disease, or those who have undergone lobectomy; 2: Those who are currently undergoing aortic balloon counterpulsation therapy (IABP) ; 3: Those who are currently receiving VV-ECMO treatment with a flow rate of >= 1.5 L/min ; 4: The results of the coagulation function tests conducted 3 days prior to signing the informed consent form and 3 days prior to the trial (including the 3 days) were judged by the research doctor to indicate severe coagulation dysfunction; 5: The puncture site has severe peripheral vascular diseases or anatomical structural changes, as well as local skin and soft tissue infections; 6: Pregnancy; 7: Currently participating in other clinical studies; 8: Those who were judged by the researchers to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Consistency in cardiac output measurement;Consistency in continuous cardiac output;

Secondary

MeasureTime frame
Consistency in GEF;Consistency in GEDV;Consistency in ITBV;Consistency in EVLW;Consistency in TB;Consistency in SV;Consistency in dPmx;Consistency in SVV;Consistency in PPV;Consistency in PART;Consistency in CPO;Consistency in SVR;

Countries

China

Contacts

Public ContactLi Shangrong

The Third Affiliated Hospital of Sun Yat-sen University

lishangr@mail.sysu.edu.cn+86 139 2600 6350

Outcome results

None listed

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