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Completed

NCT Number: NCT01388998

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

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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Key information

Conditions

Intravascular Volume Respiratory Changes

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein

Other

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.

Primary outcomes

  1. Change of dPP from start of intervention to 2 minutes after start of the intervention

    Time frame: Application of pressure for 2 minutes

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2011
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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