NCT03673475

Brief Summary

Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.

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 Feb 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

August 24, 2018

Last Update Submit

November 23, 2018

Conditions

Intravascular Volume

Outcome Measures

Primary Outcomes (1)

  • number of patients with significant change in VJI distensibility and pleth variebility index

    volume responders with significant change in jugular vein distensibility and pleth variebility index

    during surgery at day 0

Study Arms (1)

fluid responsiveness

Assessment of fluid responsiveness using pleth variebility index and jugular vein distensibility in patients undergoing major abdominal surgery

Procedure: Assessment of fluid responsiveness

Interventions

Assessment of fluid responsivenessPROCEDURE

assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery

fluid responsiveness

Eligibility Criteria

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

patients undergoing major abdominal surgery

You may qualify if:

  • American Society of Anesthesiologists(ASA) physical status I-III patients
  • patients undergoing major abdominal surgery

You may not qualify if:

  • arrythmia
  • severe right ventricle failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Yucel Karaman, ass. prof

    Tepecik TRH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 24, 2018

First Posted

September 17, 2018

Study Start

February 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)