Fluid Requirement During Surgery PVI v Doppler

Not Applicable

Completed

• Conditions: Colorectal Surgery; Major Abdominal Surgery
• Interventions: Device: Doppler; Other: PVI'

• Registration Number: NCT02142816
• Lead Sponsor: York Teaching Hospitals NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Study First Posted: 2014-05-20
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doppler	Doppler	Fluid directed by oesophageal doppler
PVI	PVI'	Fluid therapy directed by Pleth Variability Index

Primary Outcome Measures

Name	Time	Method
Difference between fluid volumes administered in the intra-operative period	End of operation

Secondary Outcome Measures

Name	Time	Method
Difference in 24 hour fluid balance	24 hours
Post-operative morbiditiy survey	7 days
Biochemical Markers of Tissue Perfusion	24 hours	Lactate and Base Excess

Trial Locations

Locations (1)

York Teaching Hospital; 🇬🇧 York, N Yorks, United Kingdom