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Haemodynamical Optimization During Brain Surgery

Primary Purpose

Brain Edema

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Hemodynamic management based on invasive fluid responsiveness parameters
Hemodynamic management based on noninvasive cardiac output and SVV measurement
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Edema focused on measuring fluid responsiveness, haemodynamical monitoring, ClearSight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Glasgow Coma scale 15
  • ASA Physical Status Classification System I-III
  • planed surgery for brain tumor to 5 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 KraloveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A invasive haemodynamical measurement

Group B non-invasive haemodynamical measurement

Arm Description

No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.

No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).

Outcomes

Primary Outcome Measures

fluid balance difference
the difference between fluid intake and output and losses during surgery will be calculated

Secondary Outcome Measures

mean dose of norepinephrine
mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery
level of creatinin
plasma level of creatinin measured on the first postoperative day
postoperative lung dysfunction
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively
length of postoperative stay
number of days of stay in the hospital after the surgery

Full Information

First Posted
September 7, 2019
Last Updated
October 6, 2021
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT04114799
Brief Title
Haemodynamical Optimization During Brain Surgery
Official Title
A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

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

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 invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
Detailed Description
The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes. This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Edema
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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A invasive haemodynamical measurement
Arm Type
Active Comparator
Arm Description
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.
Arm Title
Group B non-invasive haemodynamical measurement
Arm Type
Experimental
Arm Description
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).
Intervention Type
Procedure
Intervention Name(s)
Hemodynamic management based on invasive fluid responsiveness parameters
Intervention Description
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)
Intervention Type
Procedure
Intervention Name(s)
Hemodynamic management based on noninvasive cardiac output and SVV measurement
Intervention Description
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.
Primary Outcome Measure Information:
Title
fluid balance difference
Description
the difference between fluid intake and output and losses during surgery will be calculated
Time Frame
up to 5 hours after start of operation
Secondary Outcome Measure Information:
Title
mean dose of norepinephrine
Description
mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery
Time Frame
up to 5 hours after start of operation
Title
level of creatinin
Description
plasma level of creatinin measured on the first postoperative day
Time Frame
24 hours
Title
postoperative lung dysfunction
Description
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively
Time Frame
1 day
Title
length of postoperative stay
Description
number of days of stay in the hospital after the surgery
Time Frame
up to 2 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Glasgow Coma scale 15 ASA Physical Status Classification System I-III planed surgery for brain tumor to 5 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vlasta Dostálová, MD, Ph.D.
Phone
777883571
Email
dostavla@seznam.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Dostal, MD, Ph.D.
Phone
+420495833218
Email
pavel.dostal@fnhk.cz
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Dostal, MD, PhD
Phone
00420495833218
Email
pavel.dostal@fnhk.cz
First Name & Middle Initial & Last Name & Degree
Pavel Dostal, MD, PhD
Phone
00420495832266
Email
pavel.dostal@fnhk.cz

12. IPD Sharing Statement

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Haemodynamical Optimization During Brain Surgery

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