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

NCT01388998 | Completed

• 1 other identifier: 837.308.10(7317)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intravascular Volume; Respiratory Changes

Keywords

fluid management; fluid therapy; dPP; difference in pulse pressure; PVI; pleth variability index; external pressure applied on the caval vein

Outcome Measures

Primary Outcomes (1)

• Change of dPP from start of intervention to 2 minutes after start of the intervention

  Application of pressure for 2 minutes

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective hepatic surgery procedures (hemihepatectomy) qualifying for arterial line

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, 55131, Germany

Location

MeSH Terms

Interventions

Blood Pressure

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• Gunther Pestel, MD, PhD

  Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 7, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

DE (1)