NCT04265703

Brief Summary

Most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (IJV); however, it is recognized that evidence for other sites is, at present, limited. Besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. The investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance

Trial Health

77
On Track

Trial Health Score

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

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress73%
Feb 2024Feb 2027

First Submitted

Initial submission to the registry

February 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
4 years until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

February 9, 2020

Last Update Submit

March 10, 2026

Conditions

Critical Illness

Keywords

Central venous accessUltrasound-guided catheterizationInnominate veinBrachiocephalic vein

Outcome Measures

Primary Outcomes (1)

  • Cannulation failure rate

    Failure to cannulate selected vein at first attempt

    Baseline

Secondary Outcomes (8)

  • Central line-associated blood infection rate

    28 days

  • Collapsibility associated with failure

    Baseline

  • Cannulation number of attempts

    Baseline

  • Procedure time

    Baseline

  • Arterial puncture rate

    Baseline

  • +3 more secondary outcomes

Study Arms (3)

Internal jugular vein site

ACTIVE COMPARATOR

Ultrasound-guided central venous catheterization at internal jugular vein site

Procedure: Internal jugular vein catheterization

Subclavian vein site

ACTIVE COMPARATOR

Ultrasound-guided central venous catheterization at subclavian vein site

Procedure: Subclavian vein catheterization

Innominate vein site

ACTIVE COMPARATOR

Ultrasound-guided central venous catheterization at innominate vein site

Procedure: Innominate vein catheterization

Interventions

Internal jugular vein catheterizationPROCEDURE

Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.

Internal jugular vein site
Subclavian vein catheterizationPROCEDURE

Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.

Subclavian vein site
Innominate vein catheterizationPROCEDURE

Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.

Innominate vein site

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins

You may not qualify if:

  • Less than 18 years-old
  • Patients with previous failed attempts with non-ultrasound guided technique
  • Non-resolved pneumothorax/hemothorax at enrollment
  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Miguel Ibarra-Estrada, MD

    Hospital Civil Fray Antonio Alcalde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Ibarra-Estrada, MD

CONTACT

3317593502drmiguelibarra@hotmail.com

Guadalupe Aguirre-Avalos, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 11, 2020

Study Start

February 27, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)