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

Intravascular Volume Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673475
• Other study ID #: Meltem Cakmak
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2018
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists(ASA) physical status I-III patients

• patients undergoing major abdominal surgery

Exclusion Criteria:

• arrythmia

• severe right ventricle failure

Related Conditions & MeSH terms

• Intravascular Volume

Intervention

Procedure:
• Assessment of fluid responsiveness
assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery

Locations

Country	Name	City	State
Turkey	Tepecik Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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