NCT04618419

Brief Summary

The primary aim of the study is to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using sonogram of the internal jugular vein for assessment of vessel distensibility in relation to stroke volume variation (SVV) measaured by electrical cardiometry. The secondary aim is to evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive value for the assessment of fluid responsiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

October 20, 2020

Last Update Submit

November 1, 2020

Conditions

Keywords

CABG surgeryInternal jugular veinstroke volume variationTFC

Outcome Measures

Primary Outcomes (1)

  • fluid responsiveness after fluid challenge

    Correlation between SVV and IJVDI

    24 hours from the start of surgery

Interventions

It is a prospective observational clinical study to correlate hemodynamic monitoring between Electrical Cardiometry and internal jugular vein distensibility index by sonogram

Eligibility Criteria

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

Demographic data, hemodynamic parameters as heart rate (HR), and mean arterial blood pressure (MAP),CVP and urine output have been registered. Cardiac data derived from electrical cardiometry including: CO ,cardiac index( CI), stroke volume variation( SVV) and thoracic fluid content were also recorded. IJVDI by sonogram was assessed

You may qualify if:

  • Adults (\>18 years old) Able to provide advanced informed consent Planned for elective CABG surgery

You may not qualify if:

  • Age \< 18 years
  • Severely reduced preoperative left ventricular ejection fraction \< 40 %
  • Significant cardiac arrhythmia.
  • Significant valvular heart disease.
  • Clinically evident pulmonary disease.
  • Bilaterally inserted venous catheters (jugular or subclavian vein)
  • History of radiotherapy or surgery of the neck region.
  • Inability to obtain interpretable ultrasound images due to a difficult acoustic window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

Related Publications (2)

  • Aronson S, Nisbet P, Bunke M. Fluid resuscitation practices in cardiac surgery patients in the USA: a survey of health care providers. Perioper Med (Lond). 2017 Oct 19;6:15. doi: 10.1186/s13741-017-0071-6. eCollection 2017.

    PMID: 29075482BACKGROUND
  • Ma GG, Hao GW, Yang XM, Zhu DM, Liu L, Liu H, Tu GW, Luo Z. Internal jugular vein variability predicts fluid responsiveness in cardiac surgical patients with mechanical ventilation. Ann Intensive Care. 2018 Jan 16;8(1):6. doi: 10.1186/s13613-017-0347-5.

    PMID: 29340792BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Residentat department of anaesthesia and surgical intensive Care

Study Record Dates

First Submitted

October 20, 2020

First Posted

November 6, 2020

Study Start

May 10, 2019

Primary Completion

December 25, 2019

Study Completion

January 5, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations