NCT05956028

Brief Summary

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

July 13, 2023

Last Update Submit

March 3, 2025

Conditions

PediatricAnesthesiaCentral Venous CatheterUltrasoundInternal Jugular Vein

Keywords

ultrasoundcentral venous catheterneonatessubclavian veininternal jugular veinanesthesia

Outcome Measures

Primary Outcomes (1)

  • The first attempt success rate.

    The attempt will be considered successful when smooth insertion of the guidewire into the vein.

    1 hour

Secondary Outcomes (2)

  • Insertion time

    1 hour

  • Number of puncture attempts.

    1 hour

Study Arms (2)

(group S)

EXPERIMENTAL

receive ultrasound guided subclavian vein cannulation

Procedure: Ultrasound guided SCV cannulationProcedure: Ultrasound guided IJV cannulation

(group I)

ACTIVE COMPARATOR

receive ultrasound guided internal jugular vein cannulation

Procedure: Ultrasound guided SCV cannulationProcedure: Ultrasound guided IJV cannulation

Interventions

Ultrasound guided SCV cannulationPROCEDURE

receive ultrasound guided SCV cannulation

(group I)(group S)
Ultrasound guided IJV cannulationPROCEDURE

receive ultrasound guided IJV cannulation

(group I)(group S)

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All infants weighing less than 5 kg scheduled for major elective surgeries under general anesthesia.

You may not qualify if:

  • Parents or legally authorized personnel refusal.
  • Previous trials of central venous cannulation in the last week.
  • Emergency surgery.
  • Coagulopathy (platelets less than 20.000 and or INR more than 1.5)
  • Infection at the proposed site for cannulation.
  • Inability to visualize vein correctly by the ultrasound.
  • Neck deformity or swelling in the proposed site of cannulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, 11559, Egypt

Location

Related Publications (1)

  • Sarhan K, Abdelgawad O, Abdelhamid B, El-Ashmawi H, Soliman D, Turki D, Salah H, Badry M. Efficacy of Ultrasound-Guided Internal Jugular Vein versus Subclavian Vein Cannulation in Neonates and Infants Weighing Less Than 5 kg: A Prospective, Randomized Controlled Trial. Anaesth Crit Care Pain Med. 2025 Nov 17:101681. doi: 10.1016/j.accpm.2025.101681. Online ahead of print.

    PMID: 41260395DERIVED

Study Officials

  • Khaled Sarhan

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, Asst. professor of anesthesia, Cairo university

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

July 21, 2023

Primary Completion

March 3, 2025

Study Completion

March 3, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)