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Effectiveness of minimizing bleeding with introducer needle in CVC insertion compared to scalpel incision in patients undergoing open heart surgery

Effectiveness of minimizing bleeding with introducer needle in CVC insertion compared to scalpel incision in patients undergoing open heart surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241029001
Enrollment
150
Registered
2024-10-29
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Healthcare providers use various techniques to access central veins for catheter insertion. These techniques include making a skin incision using a scalpel as a standard procedure or using an introducer needle without a scalpel incision before applying the dilator. The insertion of a catheter into a blood vessel inherently involves puncturing the skin and underlying tissues, which may result in bleeding. Introducer needle in CVC insertion, minimizing bleeding, open heart surgery.

Interventions

During CVC placement, once the guidewire is successfully advanced and the needle removed, the proceduralist uses the introducer needle from the CVC insertion kit based on patient randomization to make
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Introducer needle puncture,Scalpel incision group

Sponsors

Department of Anesthesiology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective open heart surgery with CVC insertion at internal jugular vein 2. Patients aged 18-85 years. 3. American Society of Anesthesiologist (ASA) physical status I-IV. 4. Patients willing to participate in the research and provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with infections at the site of CVC insertion or sepsis 2. Patients who decline or request withdrawal from the research. 3. Central venous catheterization with Pulmonary artery catheterization 4. Central venous catheter size larger than 8Fr

Design outcomes

Primary

MeasureTime frame
grading of peri-catheter bleeding post operative day 0 (at the end of operation) grading into 4 levels

Secondary

MeasureTime frame
Duration between dermatotomy to the successful dilation with dilator at the beginning of study quantitative measurement (mins),Attempt of dilatation at the beginning of study ratio scale,Number of dressings used per day in post operative day 1 at the beginning of study ratio scale

Countries

Thailand

Contacts

Public ContactAbhidej Saelao

Department of Anesthesiology Faculty of Medicine Ramathibodi Hospital, Mahidol University

abhidej.seng@gmail.com0812575251

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026