Fluid Requirement During Surgery PVI v Doppler

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02142816

Acronym

PVIvDoppler

Enrollment

Registered

2014-05-20

Start date

2013-01-31

Completion date

2014-03-31

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery, Major Abdominal Surgery

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

Interventions

DEVICEDoppler

Fluid therapy guided by doppler

OTHERPVI'

Fluid therapy guided by PVI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026