Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness

Internal Jugular Vein Distensibility and Pleth Variability Index for Evaluating Fluid Responsiveness

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.

Study Overview

• Status: Completed
• Conditions: Intravascular Volume
• Intervention / Treatment: Procedure: Assessment of fluid responsiveness

Detailed Description

Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by >%10; while nonresponders will be defined as an increase in MAP <%10 or decrease in MAP.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing major abdominal surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• arrythmia
• severe right ventricle failure

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital
• Investigators: Study Chair: Yucel Karaman, ass. prof, Tepecik Trh

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Meltem Cakmak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No