Fluid Requirement During Surgery PVI v Doppler

Study Overview
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Brief Summary
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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

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

Conditions
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Colorectal Surgery, Major Abdominal Surgery

Intervention / Treatment
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* Device: Doppler
* Other: PVI'


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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