Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein

External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)

Fluid therapy optimization in the perioperative period has been considered as major contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid requirements in the anesthetized patient with arterial line is the assessment of difference in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid management approach to avoid both hypervolemia and hypovolemia. However, several clinical factors may impede dPP measurements. Surgical manipulations in abdominal procedures may interfere with hemodynamic stability due to obstruction of the caval vein. Physiological considerations make us hypothesize that only intense pressure impedes caval blood flow and thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval vein.

Study Overview

• Status: Completed
• Conditions: Intravascular Volume; Respiratory Changes
• Intervention / Treatment: Other: Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line

Exclusion Criteria:

• pregnancy
• cardiac insufficiency (NYHA 4, EF < 25 %)
• coronary (CCS 4)
• coagulopathy
• symptoms of infection or sepsis
• malignant hyperthermia
• porphyria
• oesophageal varicose veins
• absence of sinus rhythm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of dPP from start of intervention to 2 minutes after start of the intervention	Application of pressure for 2 minutes

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Lydia T. Strys, MD, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology); Principal Investigator: Dorothea Closhen, MD, PhD, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology); Study Director: Gunther Pestel, MD, PhD, Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): April 24, 2012
• Last Update Submitted That Met QC Criteria: April 22, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: fluid management; fluid therapy; PVI; pleth variability index; dPP; difference in pulse pressure; external pressure applied on the caval vein
• Other Study ID Numbers: 837.308.10(7317)