Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2010-01-31
2014-06-30
Brief Summary
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Specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (PsqO2)is increased in obese patients when fluid management is optimized by means of esophageal Doppler monitoring compared to obese patients undergoing standard fluid management.
Furthermore the investigators will test the hypothesis that PsqO2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. Thus the investigators assume that PsqO2 is similar in obese and non-obese patients when fluid management is optimized in both groups.
Detailed Description
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Fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. Subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.It is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement.
It remains unknown how to hydrate obese surgical patients best. The most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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obese control
No interventions assigned to this group
obese goal-directed
Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.
non-obese goal directed
Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.
Interventions
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Goal directed fluid therapy
Fluid will be administered to reach maximal stroke volume during the intraoperative period.
Eligibility Criteria
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Inclusion Criteria
* undergoing laparoscopic elective fundoplication or elective bariatric surgery
Exclusion Criteria
* documented coronary artery disease
* renal insufficiency
* severe chronic obstructive pulmonary disease
* symptoms of infection or sepsis
* esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).
18 Years
65 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Barbara Kabon
PD. MD.
Principal Investigators
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Barbara Kabon, MD
Role: PRINCIPAL_INVESTIGATOR
MUW
Locations
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Department of Anesthesiology, Medical University of Vienna
Vienna, , Austria
Countries
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References
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Kabon B, Nagele A, Reddy D, Eagon C, Fleshman JW, Sessler DI, Kurz A. Obesity decreases perioperative tissue oxygenation. Anesthesiology. 2004 Feb;100(2):274-80. doi: 10.1097/00000542-200402000-00015.
Fleischmann E, Kurz A, Niedermayr M, Schebesta K, Kimberger O, Sessler DI, Kabon B, Prager G. Tissue oxygenation in obese and non-obese patients during laparoscopy. Obes Surg. 2005 Jun-Jul;15(6):813-9. doi: 10.1381/0960892054222867.
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Muhlbacher J, Luf F, Zotti O, Herkner H, Fleischmann E, Kabon B. Effect of Intraoperative Goal-Directed Fluid Management on Tissue Oxygen Tension in Obese Patients: a Randomized Controlled Trial. Obes Surg. 2021 Mar;31(3):1129-1138. doi: 10.1007/s11695-020-05106-x. Epub 2020 Nov 27.
Other Identifiers
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708/2009, local IRB
Identifier Type: -
Identifier Source: org_study_id