Fluid Requirement During Surgery PVI v Doppler

NCT02142816 | Completed DMC

• 1 other identifier: YOR-A02089
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Surgery; Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Difference between fluid volumes administered in the intra-operative period

  End of operation

Secondary Outcomes (3)

• Difference in 24 hour fluid balance

  24 hours

• Post-operative morbiditiy survey

  7 days

• Biochemical Markers of Tissue Perfusion

  24 hours

Study Arms (2)

Doppler

ACTIVE COMPARATOR

Fluid directed by oesophageal doppler

Device: Doppler

PVI

ACTIVE COMPARATOR

Fluid therapy directed by Pleth Variability Index

Other: PVI'

Interventions

Doppler DEVICE

Fluid therapy guided by doppler

Doppler

PVI' OTHER

Fluid therapy guided by PVI

PVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major abdominal surgery
• Anaerobic Threshold \>11 ml O2/kg/min
• VE/VCO2 \<34 OR
• Low risk according to Consultant anaesthetist

You may not qualify if:

• 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

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

York Teaching Hospital

York, N Yorks, YO318HE, United Kingdom

Location

MeSH Terms

Interventions

Echocardiography, Doppler

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• David Yates, MB ChB

  York Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 20, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

GB (1)