NCT05119985

Brief Summary

This study evaluates two different techniques for peripheral venous cannulation in operating theatre. Ultrasound guided insertion of peripheral cannula in comparison with conventional approach without any ultrasound guidance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 2, 2021

Last Update Submit

December 18, 2024

Conditions

Keywords

ultrasoundveincannulation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Successful Securing of Peripheral Vein on First Attempt

    Comparing success rate of securing peripheral vein for first attempt in both methods.

    60 minutes

Secondary Outcomes (3)

  • Number of Needed Attempts to Successful Securing of Peripheral

    60 minutes

  • Number of Complication After and During Securing Peripheral Vein

    24 hours

  • Time Needed to Secure Peripheral Vein

    60 minutes

Study Arms (2)

Ultrasound guided cannulation

ACTIVE COMPARATOR

Ultrasound guided insertion of peripheral vein cannula.

Procedure: Peripheral vein cannulation

Cannulation without ultrasound

ACTIVE COMPARATOR

Catheter insertion by conventional approach, without ultrasound guidance

Procedure: Cannulation without ultrasound

Interventions

The target vein is directly identified by ultrasound, the procedure of peripheral venous catheter insertion is performed conventionally, without ultrasound guidance

Ultrasound guided cannulation

Cannulation is done the conventional way without any ultrasound use.

Cannulation without ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years

You may not qualify if:

  • Age \<18 years
  • Patient disagreement with the insertion of peripheral venous catheter
  • Contraindication of ultrasound examination of the venous system
  • Contraindication of the introduction of peripheral venous cannula on both upper limbs
  • Necessity of securing other vein access than peripheral
  • Contraindications of cannulation of peripheral vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.

Ústí nad Labem, Ústí Nad Labem Region, 40001, Czechia

Location

Related Publications (1)

  • Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

MeSH Terms

Interventions

CatheterizationHigh-Energy Shock Waves

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are divided by block randomization into two arms. Arm A peripheral vein cannulation with ultrasound guidance and Arm B conventional cannulation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MUDr.

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

December 1, 2021

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations