NCT03030898

Brief Summary

The idea of this work came during a carotid surgery, when we noticed a respiratory variation of the right internal jugular vein. Also, because of the interest of evaluating the preload dependence during an intervention or reanimation where it is difficult to access the other monitoring methods . The aim of the study was to test the hypothesis that respiratory changes in right internal jugular vein diameter are similar to respiratory changes in superior and inferior vena cava in mechanically ventilated patients and therefore help to predict fluid responsiveness.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
unknown

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 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 19, 2017

Last Update Submit

January 21, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Respiratory Variation of the Right Internal Jugular Vein ∆DRIJV

    Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .

    through study completion, an average of 1 year

  • Respiratory Variation of the superior vena cava ∆DSVC

    Difference (Δ) between the maximum and the minimum diameter value/maximum diameter .

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Respiratory Variation of the inferior vena cava ∆DIVC

    through study completion, an average of 1 year

Study Arms (1)

respiratory variation of the right internal jugular vein

OTHER
Diagnostic Test: respiratory variation of the right internal jugular vein

Interventions

respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena

respiratory variation of the right internal jugular vein

Eligibility Criteria

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

You may qualify if:

  • older than 18 years
  • Mechanical Ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Anis Lebbi

    Military Hospital of Tunis

    STUDY DIRECTOR
  • Mejdi Ferjaoui

    Military Hospital of Tunis

    PRINCIPAL INVESTIGATOR
  • Trabelsi Walid

    Military Hospital of Tunis

    STUDY CHAIR
  • Abdelkader Ben Gabsia

    Military Hospital of Tunis

    STUDY CHAIR
  • Emel Rafrafi

    Military Hospital of Tunis

    STUDY CHAIR
  • Amine Skouri

    Military Hospital of Tunis

    STUDY CHAIR
  • Kaouther Fares

    Military Hospital of Tunis

    STUDY CHAIR
  • Walid Sallami

    Military Hospital of Tunis

    STUDY CHAIR
  • Iheb Labbene

    Military Hospital of Tunis

    STUDY CHAIR
  • Mustapha Ferjani

    Military Hospital of Tunis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 25, 2017

Study Start

January 1, 2017

Primary Completion

April 25, 2017

Study Completion

December 28, 2017

Last Updated

January 25, 2017

Record last verified: 2017-01