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

J

Johannes Gutenberg University (JGU)

Status

Completed

Conditions

Intravascular Volume
Respiratory Changes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01388998
837.308.10(7317)

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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