Fluid Requirement During Surgery PVI v Doppler (PVIvDoppler)

May 15, 2014 updated by: York Teaching Hospitals NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • N Yorks
      • York, N Yorks, United Kingdom, YO318HE
        • York Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Patients with a previously diagnosed dysrhythmia
  • Patients who weight >100kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Doppler
Fluid directed by oesophageal doppler
Device: Doppler
Fluid therapy guided by doppler
Active Comparator: PVI
Fluid therapy directed by Pleth Variability Index
Other: PVI'
Fluid therapy guided by PVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between fluid volumes administered in the intra-operative period
Time Frame: End of operation
End of operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in 24 hour fluid balance
Time Frame: 24 hours
24 hours
Post-operative morbiditiy survey
Time Frame: 7 days
7 days
Biochemical Markers of Tissue Perfusion
Time Frame: 24 hours
Lactate and Base Excess
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

York Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: David Yates, MB ChB, York Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • YOR-A02089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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