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Completed

NCT Number: NCT05045352

Echogenic Versus Non-echogenic Needles for Venous Access

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

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Key information

Conditions

Anesthesia Vascular Access Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

Patients undergoing certain surgical procedures and patients in intensive care unit require a central venous catheter (CVC) for infusion of medicaments and for monitoring. Central venous access (CVA) can be performed both with a blind technique or an ultrasound guided technique. A common place for CVA is the subclavian vein.

While many guidelines recommend the use of ultrasound for jugular access, there are no explicit recommendations for subclavian CVA For ultrasound guided CVA procedures good needle visualization is important to successfully place the needle and catheter in the correct position.

Echogenic needles can give better needle visualization when performing ultrasound guided CVA procedures. Theoretically, the use of echogenic needles should improve performance time and success rates, and reduce complication rates due to a better needling control.

The investigators will investigate the use of echogenic needles for vascular access.

A prospective randomized controlled trial design will be used. Echogenic needles will be compared with non-echogenic (standard) needles. The main null hypothesis states that there is no difference in access time between the needles.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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Exclusion criteria

  • 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.

Treatment and study plan

echogenic needles for intravenous access

Device

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

Primary outcomes

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

    Time frame: 10 sec - 240 sec

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

Secondary outcomes

  1. Time from skin puncture until catheter in place

    Time frame: 60 sec - 600 sec

    Time from skin puncture until the catheter in place in the subclavian vein.

  2. Success with venous access in first needling attempt

    Time frame: 60 sec - 600 sec

    Success in first attempt is defined as one skin puncture and directly into the subclavian vein

  3. Number of needling attempts before venous access

    Time frame: 60 sec - 600 sec

    Number of attempts is defined as the counted number of needle attempts intermitted by a needle withdrawal of at least 0.5 cm until aspiration of venous blood.

  4. Number of skin punctures

    Time frame: 60 sec - 600 sec

    Number of skin punctures is defined as the counted number of skin punctures until aspiration of venous blood.

  5. The procedure was aborted

    Time frame: 2 minutes - 20 minutes

    Discontinuation of the procedure or change of site for vascular access

  6. Localization of catheter tip in x-ray

    Time frame: 1 day- 7 days

    Catheter misplacement judged by x-ray. X-ray will be performed after the surgery and a blinded observer will describe the localization of the catheter.

  7. The anaesthetists subjective experience with needle visualization

    Time frame: 3 min- 20 min

    After performing the vascular access the anaesthetists are asked about how they found the visualization of the needle using a Numeric Rating Scale

  8. The anaesthetists subjective experience with the needle placement

    Time frame: 3 minutes - 20 minutes

    After performing the vascular access the anaesthetist is asked how the needle placement was using a Numeric Rating Scale

  9. Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax

    Time frame: 1 minutes- 1 day

    Adverse events, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized for safety information

  10. Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax

    Time frame: 5 minutes - 1 week

    Adverse device effects, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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