Fluid Requirement During Surgery PVI v Doppler

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

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

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Detailed Description

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Conditions

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Colorectal Surgery Major Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Doppler

Fluid directed by oesophageal doppler

Group Type ACTIVE_COMPARATOR

Doppler

Intervention Type DEVICE

Fluid therapy guided by doppler

PVI

Fluid therapy directed by Pleth Variability Index

Group Type ACTIVE_COMPARATOR

PVI'

Intervention Type OTHER

Fluid therapy guided by PVI

Interventions

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Doppler

Fluid therapy guided by doppler

Intervention Type DEVICE

PVI'

Fluid therapy guided by PVI

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No