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Clinical Trials/NCT03644654
NCT03644654
Completed
Not Applicable

Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method

University Hospital Hradec Kralove1 site in 1 country100 target enrollmentAugust 21, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
University Hospital Hradec Kralove
Enrollment
100
Locations
1
Primary Endpoint
intraoperative fluid balance
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.

Detailed Description

The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.

Registry
clinicaltrials.gov
Start Date
August 21, 2018
End Date
July 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dostalova Vlasta, MD, PhD

Principal Investigator

University Hospital Hradec Kralove

Eligibility Criteria

Inclusion Criteria

  • Glasgow Coma scale 15
  • ASA Physical Status Classification System I-III
  • planed spinal surgery to 3 hours
  • postoperative awakening
  • sinus rhythm

Exclusion Criteria

  • NYHA III, IV
  • BMI over 40 in females and over 35 in men
  • awake operation
  • postoperative artificial ventilation

Outcomes

Primary Outcomes

intraoperative fluid balance

Time Frame: 5 hours

the difference between fluid intake and output and losses during surgery

Secondary Outcomes

  • level of creatinine(24 hours)
  • mean dose of norepinephrine(5 hours)
  • pooperative lung dysfunction(24 hours)
  • the length of postoperative stay(till 2 months after surgery)

Study Sites (1)

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