Echogenic Versus Non-echogenic Needles for Venous Access

NCT05045352 | Completed

• 1 other identifier: REK 85090
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.

Conditions

Anesthesia; Vascular Access Complication

Keywords

vascular access,; ultrasound guided; echogenic needles

Outcome Measures

Primary Outcomes (1)

• Time from skin puncture of the needle until aspiration of venous blood.

  Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access

  10 sec - 240 sec

Secondary Outcomes (10)

• Time from skin puncture until catheter in place

  60 sec - 600 sec

• Success with venous access in first needling attempt

  60 sec - 600 sec

• Number of needling attempts before venous access

  60 sec - 600 sec

• Number of skin punctures

  60 sec - 600 sec

• The procedure was aborted

  2 minutes - 20 minutes

Study Arms (2)

Echogenic needle

ACTIVE COMPARATOR

venous access performed under ultrasound guidance with echogenic needles

Device: echogenic needles for intravenous access

Non-Echogenic needles

NO INTERVENTION

venous access performed under ultrasound guidance with non-echogenic needles

Interventions

echogenic needles for intravenous access DEVICE

echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure

Echogenic needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent.

You may not qualify if:

• Patients that do not speak or understand Norwegian language.
• Skin disease or infection affecting the whole-body surface or within the area of examination.
• Patients with untreated coagulopathy
• Known vascular abnormality
• Any reason why, in the opinion of the investigators, the patient should not participate.
• Subject participates in a potentially confounding drug or device trial during the course of the study.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Study Officials

• Trine Kåsine, MD

  Department of Anaesthesiology Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be anesthetized and asleep Outcome assessor will not be in the operating theater during the procedure
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two arms Venous access either with echogenic needles or with non-echogenic needles

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 16, 2021
• Study Start: January 12, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)