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Feasibility and Accuracy of Non-invasive and Hands-free Ultrasonic Patch for Continuous Monitoring of Cardiac Output in Critically Ill Patients: A Diagnostic Accuracy Study Based on PiCCO

Feasibility and Accuracy of Non-invasive and Hands-free Ultrasonic Patch for Continuous Monitoring of Cardiac Output in Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107413
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Critically Ill Patients

Interventions

Gold Standard:In this study, invasive PiCCO transpulmonary thermodilution (TD-CO) measurement is used as the gold standard to evaluate the accuracy of the non-handheld carotid Doppler ultrasound (CDU)
Index test:The diagnostic test (index test) to be evaluated in this study is the non-handheld carotid Doppler ultrasound (CDU) system. This device obtains carotid blood flow velocity and volume parame

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years (no gender restriction). (2) Patients: Those admitted to the Intensive Care Unit (ICU) with hemodynamic instability, requiring fluid resuscitation or the use of vasoactive drugs. (3) Vascular Access: Presence of a radial artery or femoral artery catheter to enable invasive hemodynamic monitoring via PiCCO (Pulse Index Continuous Cardiac Output). (4) Informed Consent: Written informed consent obtained from the patient or their family members, with relevant documents signed.

Exclusion criteria

Exclusion criteria: (1) Severe peripheral vascular disease, anatomical structural changes, or local skin and soft tissue infection at the puncture site; severe coagulation dysfunction. (2) Relative contraindications include heparin allergy, local infection at the puncture site; patients receiving intra-aortic balloon pump therapy, hemorrhagic diseases; aortic aneurysm, Takayasu arteritis; arterial stenosis, history of limb embolism; lobectomy, pulmonary embolism, large intrathoracic space-occupying lesions; during cardiopulmonary bypass; excessive short-term fluctuations in body temperature or blood pressure; severe arrhythmias; severe pneumothorax, cardiopulmonary compressive disorders; intracardiac tumors; intracardiac shunts, etc. (3) Infection, dermatitis, cellulitis, burns, trauma, or other conditions in the puncture site or adjacent tissues. (4) Presence of venous injury, embolism at the proximal end of the vein where the catheter is to be placed, or potential arteriovenous fistula. (5) The ipsilateral upper limb of patients who have undergone radical mastectomy, cardiac pacemaker implantation, or axillary lymph node dissection. (6) Superior vena cava syndrome; inability to cooperate or restlessness. (7) Neck wounds that prevent the application of adhesive patches.

Design outcomes

Primary

MeasureTime frame
Continuous cardiac output;Sensitivity;Specificity;receiver operating curve;

Secondary

MeasureTime frame
Physiological parameters of carotid blood flow;

Countries

China

Contacts

Public ContactQuanhong Zhou

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

zhouanny@hotmail.com+86 137 6144 1463

Outcome results

None listed

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