NCT03745209

Brief Summary

This is a randomized controlled single-center study that will be conducted in the intensive care unit. The main objective of this study is to assess the success rate of ultrasound-guided peripheral intravenous cannulation in ICU patients with difficult intravenous access compared with traditional landmark technique.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

September 9, 2018

Last Update Submit

February 10, 2019

Conditions

Keywords

Peripheral IVDifficultUltrasound-guided

Outcome Measures

Primary Outcomes (1)

  • Overall success rate of IV placement

    Ability to establish a functioning peripheral IV catheter

    Up to 30 minutes

Secondary Outcomes (4)

  • Number of skin punctures attempted.

    Up to 30 minutes

  • 24 hours catheter survival

    24 hours post IV insertion

  • Complications

    Up to 7 days

  • Subsequent need for PICC or central line.

    Up to 14 days

Study Arms (2)

Ultrasound-guided peripheral IV.

EXPERIMENTAL

Ultrasound-guided peripheral IV cannulation

Device: Ultrasound

Traditional landmark technique

NO INTERVENTION

Traditional landmark technique

Interventions

Use of real-time ultrasound in an attempt to establish intravenous peripheral catheter.

Ultrasound-guided peripheral IV.

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Difficult IV access patients after 2 failed attempts

You may not qualify if:

  • Upper-extremity cellulitis
  • Unstable and need urgent intravenous access( central line or IO).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

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

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mohammed R Alshamsi, MD

    Kingston Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed R ALshamsi, MD

CONTACT

Fadi A Alsulaimi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical fellow

Study Record Dates

First Submitted

September 9, 2018

First Posted

November 19, 2018

Study Start

January 21, 2019

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations