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Completed

NCT Number: NCT02142816

Fluid Requirement During Surgery PVI v Doppler

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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Key information

Conditions

Colorectal Surgery Major Abdominal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York Teaching Hospital

York, N Yorks, YO318HE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler

Device

Fluid therapy guided by doppler

PVI'

Other

Fluid therapy guided by PVI

Primary outcomes

  1. Difference between fluid volumes administered in the intra-operative period

    Time frame: End of operation

Secondary outcomes

  1. Difference in 24 hour fluid balance

    Time frame: 24 hours

  2. Post-operative morbiditiy survey

    Time frame: 7 days

  3. Biochemical Markers of Tissue Perfusion

    Time frame: 24 hours

    Lactate and Base Excess

Sponsors and collaborators

Lead sponsor

York Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PVIvDoppler

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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