NCT04274881

Brief Summary

The primary aim of this study is to derive a prediction rule to estimate the required length for placement of the CVC tip at the mid-point of the SVC from simple anatomical landmarks that are consistent with the known surface projections of the great veins. The accuracy of this rule will be examined using TEE and is intended for adult patients undergoing cannulation of the right IJV utilizing a middle approach. As a secondary aim, we will examine the performance of this suggested rule as contrasted with two other popular methods for estimation of the CVC length, the Peres formula and the C-length method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

February 16, 2020

Last Update Submit

April 29, 2025

Conditions

Keywords

Surface landmarksC-lengthCentral venous catheterizationInternal jugular veinPredictionAccuracy

Outcome Measures

Primary Outcomes (2)

  • Accuracy of surface landmarks for prediction of CVC depth required to place the CVC tip at the mid-SVC.

    Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall.

    Outcome will be assessed at completion of catheterization procedure

  • Accuracy of C-length for prediction of CVC depth required to place the CVC tip at the mid-SVC.

    Difference between actual length required to place the CVC tip at the mid-SVC as guided by TEE and the C-length.

    Outcome will be assessed at completion of catheterization procedure

Interventions

The right internal jugular vein will be cannulated under transesophageal echocardiographic (TEE) guidance in order to place the catheter tip in the mid-SVC. The length of the catheter required to place the tip at the mid-SVC as guided by TEE will be regressed on the C-length or on the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall in order to obtain a predictive equation. The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest).

Also known as: Transesophageal echocardiography (to guide placement of central venous catheter tip at mid-SVC)

Eligibility Criteria

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

Adult subjects of either sex who are scheduled for elective cardiac surgery in whom echocardiography is indicated or recommended will be eligible.

You may qualify if:

  • Adult subjects (age 18 years or older).
  • Elective cardiac surgery.
  • Echocardiography is indicated or recommended.

You may not qualify if:

  • Previous cardiothoracic or neck surgery.
  • Previous radiotherapy on the neck or chest.
  • Intra-thoracic or neck mass lesions.
  • Deformity of the chest wall.
  • Anomalies of the great vessels.
  • Congenital heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11517, Egypt

Location

Study Officials

  • Sameh M Hakim, MD

    Ain Shamd University, Faculty of Medicine, Department of Anesthesiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology, Intensive Care and Pain Management

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

October 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations