Perioperative Fluid Therapy Optimization in Spinal Surgery

Not Applicable

Completed

• Conditions: Hypervolemia; Hypovolemia
• Interventions: Procedure: Standard care group; Procedure: Noninvasive monitoring group

• Registration Number: NCT03644654
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study Start: 2018-08-21
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Primary Completion: 2020-04-30
• Study Completion: 2020-07-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care group	Standard care group	Fluid management will be done according standard care
Noninvasive monitoring group	Noninvasive monitoring group	Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)

Primary Outcome Measures

Name	Time	Method
intraoperative fluid balance	5 hours	the difference between fluid intake and output and losses during surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia