Back to resultsPerioperative Fluid Therapy Optimization in Spinal Surgery
Primary Purpose
Hypovolemia, Hypervolemia
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Standard care group
Noninvasive monitoring group
Sponsored by
About this trial
This is an interventional treatment trial for Hypovolemia focused on measuring fluid responsiveness, haemodynamical monitoring, ClearSight
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
Sites / Locations
- University Hospital Hradec Kralove
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care group
Noninvasive monitoring group
Arm Description
Fluid management will be done according standard care
Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)
Outcomes
Primary Outcome Measures
intraoperative fluid balance
the difference between fluid intake and output and losses during surgery
Secondary Outcome Measures
mean dose of norepinephrine
mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery
level of creatinine
plasma level of creatinine measured on the first postoperative day
pooperative lung dysfunction
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively
the length of postoperative stay
the length of postoperative stay in hospital
Full Information
NCT ID
NCT03644654
First Posted
August 21, 2018
Last Updated
November 25, 2022
Sponsor
University Hospital Hradec Kralove
1. Study Identification
Unique Protocol Identification Number
NCT03644654
Brief Title
Perioperative Fluid Therapy Optimization in Spinal Surgery
Official Title
Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia, Hypervolemia
Keywords
fluid responsiveness, haemodynamical monitoring, ClearSight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
Fluid management will be done according standard care
Arm Title
Noninvasive monitoring group
Arm Type
Experimental
Arm Description
Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards)
Intervention Type
Procedure
Intervention Name(s)
Standard care group
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Noninvasive monitoring group
Intervention Description
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).
Primary Outcome Measure Information:
Title
intraoperative fluid balance
Description
the difference between fluid intake and output and losses during surgery
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
mean dose of norepinephrine
Description
mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery
Time Frame
5 hours
Title
level of creatinine
Description
plasma level of creatinine measured on the first postoperative day
Time Frame
24 hours
Title
pooperative lung dysfunction
Description
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively
Time Frame
24 hours
Title
the length of postoperative stay
Description
the length of postoperative stay in hospital
Time Frame
till 2 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Dostal, MD, Ph.D.
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
36422222
Citation
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.
Results Reference
result
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Perioperative Fluid Therapy Optimization in Spinal Surgery
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