NCT02986542

Brief Summary

The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages. This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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 18, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2018

Completed
Last Updated

April 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

November 18, 2016

Last Update Submit

April 2, 2018

Conditions

Keywords

newborns,femoral artery, catheterization

Outcome Measures

Primary Outcomes (1)

  • Femoral artery catheterization puncture duration

    1 - 5 minutes

Secondary Outcomes (6)

  • Number of Attempts

    5 minutes

  • Rate of Success of First Attempt

    1 - 5 minutes

  • Distance of femoral artery to skin

    1 - 5 minutes

  • Distance of femoral artery to inguinal ligament

    1 - 5 minutes

  • Femoral artery diameter

    1 - 5 minutes

  • +1 more secondary outcomes

Study Arms (2)

USG with the in-plane technique

ACTIVE COMPARATOR

Intervention: Femoral artery catheterization under USG guidance with the in-plane technique.Patients will have their femoral arterial lines inserted under the guidance of USG. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD

Procedure: Femoral artery catheterization

USG with the out-of-plane technique

ACTIVE COMPARATOR

Intervention: Under USG guidance femoral artery catheterization will be done with the probe placed for the out-of-plane technique. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD

Procedure: Femoral artery catheterization

Interventions

The intervention will be performed by a single experienced individual.

USG with the in-plane techniqueUSG with the out-of-plane technique

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling

You may not qualify if:

  • Local infection
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü Imam Üniversity

Kahramanmaraş, Türkiye, 46000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung DiseasesMetabolic DiseasesSepsis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesNutritional and Metabolic DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ömer Faruk Boran

    Kahramanmaraş Üniversitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

December 8, 2016

Study Start

December 1, 2016

Primary Completion

March 25, 2018

Study Completion

April 2, 2018

Last Updated

April 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations