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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lydia T. Strys, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01388998
First received: July 5, 2011
Last updated: April 22, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Intravascular Volume
Respiratory Changes
Other: Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: External Pressure Applied on the Caval Vein and Its Effects on Difference in Pulse Pressure (dPP) and Pleth Variability Index (PVI)

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Change of dPP from start of intervention to 2 minutes after start of the intervention [ Time Frame: Application of pressure for 2 minutes ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein
    Following hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01388998

Locations
Germany
Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)
Mainz, Germany, 55131
Sponsors and Collaborators
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)
  More Information

No publications provided

Responsible Party: Lydia T. Strys, M.D., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01388998     History of Changes
Other Study ID Numbers: 837.308.10(7317)
Study First Received: July 5, 2011
Last Updated: April 22, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
fluid management
fluid therapy
dPP
difference in pulse pressure
PVI
pleth variability index
external pressure applied on the caval vein

ClinicalTrials.gov processed this record on July 24, 2014