NCT03812757

Brief Summary

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 18, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

12 months

First QC Date

January 19, 2019

Last Update Submit

November 1, 2020

Conditions

Keywords

Central venous catheterSubclavian veinSupraclavicular fossa ultrasound view

Outcome Measures

Primary Outcomes (1)

  • Correct catheter tip positioning

    Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).

    Post-procedural x-ray (typically within 24 hours)

Secondary Outcomes (1)

  • Mechanical complications within 24 hours

    Within 24 hours after central venous catheterization

Study Arms (1)

Supraclavicular fossa US scanning

Following insertion of at least 20 cm of the guidewire into the right subclavian vein, the probe is shifted to the right supraclavicular fossa to scan the right internal jugular vein in order to exclude malposition of the guidewire. The probe is then tilted in a caudal direction to obtain a view of the guidewire within the superior vena cava. Misplaced guidewires will be corrected under real-time ultrasound guidance.

Diagnostic Test: Supraclavicular fossa US scanning

Interventions

As previously stated.

Supraclavicular fossa US scanning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients \>18 years with an indication for CVC placement and under the care of one of three intensivists responsible for the study will be consecutively included in the study

You may qualify if:

  • Indication for central venous catheter placement.

You may not qualify if:

  • Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),
  • Subclavian vein catheterization deemed inappropriate by the operator,
  • Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skånes universitetssjukhus

Lund, 22185, Sweden

Location

Related Publications (1)

  • Adrian M, Kander T, Lunden R, Borgquist O. The right supraclavicular fossa ultrasound view for correct catheter tip positioning in right subclavian vein catheterisation: a prospective observational study. Anaesthesia. 2022 Jan;77(1):66-72. doi: 10.1111/anae.15534. Epub 2021 Jul 14.

Study Officials

  • Ola Borgquist, MD, PhD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 19, 2019

First Posted

January 23, 2019

Study Start

January 18, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations