Perioperative Fluid Therapy Optimization in Spinal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Hypovolemia; Hypervolemia
• Intervention / Treatment: Procedure: Standard care group; Procedure: Noninvasive monitoring group

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Hradec Kralove, Czechia, 50005
    • University Hospital Hradec Kralove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard care group; Fluid management will be done according standard care	Procedure: Standard care group; Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).
EXPERIMENTAL: Noninvasive monitoring group; Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)	Procedure: Noninvasive monitoring group; Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative fluid balance	the difference between fluid intake and output and losses during surgery	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean dose of norepinephrine	mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery	5 hours
level of creatinine	plasma level of creatinine measured on the first postoperative day	24 hours
pooperative lung dysfunction	postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively	24 hours
the length of postoperative stay	the length of postoperative stay in hospital	till 2 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove

Publications and helpful links

General Publications

• Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2018
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): July 30, 2020

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: fluid responsiveness, haemodynamical monitoring, ClearSight
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: UHospital Hradec Kralove

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No