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Clinical Trials/NCT02142816
NCT02142816
Completed
Not Applicable

Non-invasive Assessment of Fluid Requirement During Surgery: a Comparison of Oesophageal Doppler and Pleth Variability Index

York Teaching Hospitals NHS Foundation Trust1 site in 1 country38 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Surgery
Sponsor
York Teaching Hospitals NHS Foundation Trust
Enrollment
38
Locations
1
Primary Endpoint
Difference between fluid volumes administered in the intra-operative period
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications.

Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give.

The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery.

The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
March 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
York Teaching Hospitals NHS Foundation Trust
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Major abdominal surgery
  • Anaerobic Threshold \>11 ml O2/kg/min
  • VE/VCO2 \<34 OR
  • Low risk according to Consultant anaesthetist

Exclusion Criteria

  • Patients age less than 18
  • Patient refused consent
  • Patient unable to give consent
  • Patient has had \<24hrs to consider the Patient information Sheet
  • Contraindication to Doppler Probe being inserted
  • Emergency Procedure
  • Patient has a ASA Grade 5
  • Patient is receiving dialysis treatment
  • Patient has a known hypersensitivity to hydroxyethyl starch or gelatin solutions
  • Patients with renal failure with oliguria or anuria - not related to hypovolaemia

Outcomes

Primary Outcomes

Difference between fluid volumes administered in the intra-operative period

Time Frame: End of operation

Secondary Outcomes

  • Difference in 24 hour fluid balance(24 hours)
  • Post-operative morbiditiy survey(7 days)
  • Biochemical Markers of Tissue Perfusion(24 hours)

Study Sites (1)

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