Fluid Requirement During Surgery PVI v Doppler

Colorectal Surgery Clinical Trial

— PVIvDoppler  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142816
• Other study ID #: YOR-A02089
• Status: Completed
• Phase: N/A
• First received: May 15, 2014
• Last updated: May 15, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: York Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Surgery
• Major Abdominal Surgery

Intervention

Device:
• Doppler
Fluid therapy guided by doppler

Other:
• PVI`
Fluid therapy guided by PVI

Locations

Country	Name	City	State
United Kingdom	York Teaching Hospital	York	N Yorks

Sponsors (1)

Lead Sponsor	Collaborator
York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between fluid volumes administered in the intra-operative period		End of operation	No
Secondary	Difference in 24 hour fluid balance		24 hours	No
Secondary	Post-operative morbiditiy survey		7 days	No
Secondary	Biochemical Markers of Tissue Perfusion	Lactate and Base Excess	24 hours	No