Feasibility analysis of ultrasound-assisted 3D printing tool guided radial artery puncture

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082592

Enrollment

Unknown

Registered

2024-04-01

Start date

2024-04-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Surgery requiring radial artery catheterization

Interventions

3D-Printed Tool Group:Radial artery puncture is performed using ultrasound guidance combined with 3D printing tools, and DNTP technology is used for catheter placement.

DNTP Group:Radial artery catheterization using ultrasound guidance combined with dynamic needle tip positioning (DNTP) technology

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-90 years old; 2.The ASA (American Society of Anesthesiologists) grading standard is in the ?-? level, and the elective operation patients who need radial artery puncture and catheterization during the operation; 3.Sign the subject's informed consent.

Exclusion criteria

Exclusion criteria: 1. Improved Allen test positive or radial artery puncture catheterization performed within 30 days; 2. Injury, infection, or hematoma at the intended puncture site. 3. Pregnant and lactating women; 4. Hemodynamic instability after anesthesia requires medication intervention; 5. The situation where the intended puncture side forearm needs to be used during surgery; 6: Individuals who are unable to provide sufficient informed consent due to intellectual or behavioral impairments.

Design outcomes

Primary

Measure	Time frame
First attempt success rate;	—

Secondary

Measure	Time frame
Total operation time;Intra-arterial catheter length;Needle tip position score;Time of puncture;Time of catheterization;Number of needle tip adjustment;Number of probe movements;Number of catheterization attempts;Incidence of hematoma;Incidence of vasospasm;Incidence of ischemic necrosis of distal limbs;incidence of intimal arterial dissection;Incidence of penetrating the posterior wall of blood vessels;Weather the puncture point red and swollen 6 hours after surgery;Weather the puncture point red and swollen 24 hours after surgery;Weather the distal limbs have ischemia 6 hours after surgery;Weather the distal limbs have ischemia 24 hours after surgery;Puncture point discomfort grade 6 hours after surgery;Puncture point discomfort grade 24 hours after surgery;	—

Measure

Time frame

Total operation time;Intra-arterial catheter length;Needle tip position score;Time of puncture;Time of catheterization;Number of needle tip adjustment;Number of probe movements;Number of catheterization attempts;Incidence of hematoma;Incidence of vasospasm;Incidence of ischemic necrosis of distal limbs;incidence of intimal arterial dissection;Incidence of penetrating the posterior wall of blood vessels;Weather the puncture point red and swollen 6 hours after surgery;Weather the puncture point red and swollen 24 hours after surgery;Weather the distal limbs have ischemia 6 hours after surgery;Weather the distal limbs have ischemia 24 hours after surgery;Puncture point discomfort grade 6 hours after surgery;Puncture point discomfort grade 24 hours after surgery;

—

Countries

China

Contacts

Public ContactHaoyang Geng

Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine

dayon1988@163.com+86 180 3178 2781

Outcome results

None listed

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