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

July 5, 2011
April 22, 2012
January 2011
January 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01388998 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
  • Intravascular Volume
  • Respiratory Changes
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01388998
837.308.10(7317)
No
Lydia T. Strys, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
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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)
Johannes Gutenberg University Mainz
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP