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

Not Applicable

Completed

• Conditions: Intravascular Volume; Respiratory Changes

• Registration Number: NCT01388998
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-22
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change of dPP from start of intervention to 2 minutes after start of the intervention	Application of pressure for 2 minutes

Trial Locations

Locations (1)

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology); 🇩🇪 Mainz, Germany