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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388998
First Posted: July 7, 2011
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lydia T. Strys, Johannes Gutenberg University Mainz
  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 (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 Lydia T. Strys, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Submitted: July 5, 2011
First Posted: July 7, 2011
Last Update Posted: April 24, 2012
Last Verified: April 2012

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