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Cardiac Output and Duplex Sonography in Carotid Endarterectomy

Primary Purpose

Carotid Stenosis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Regional anesthesia
General anesthesia
Transcranial Doppler ultrasonography
blood gas analysis
invasive arterial blood pressure measurement
arterial blood gas measurement
Neurological Control
NIRS monitoring
oxygen supply (not invasive 'Vigileo')
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carotid Stenosis focused on measuring carotid endarterectomy, cardiac output, trans-cranial Doppler, CEA, regional anesthesia, general anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  1. Age >= 18 years
  2. Elective carotid endarterectomy
  3. Signed informed consent

Exclusion Criteria:

  1. Age under 18 years
  2. Missing signed informed consent

Sites / Locations

  • Medical University Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Regional anesthesia (RA)

General anesthesia (GA)

Arm Description

Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')

General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')

Outcomes

Primary Outcome Measures

Influence of anesthetic technique on cardiac output during carotid endarterectomy.
Number of participants: 90 patients Unit of measure: Cardiac index (l/m2) Cardiac output will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture

Secondary Outcome Measures

Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.
Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture

Full Information

First Posted
July 31, 2014
Last Updated
September 6, 2021
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT02230358
Brief Title
Cardiac Output and Duplex Sonography in Carotid Endarterectomy
Official Title
Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.
Detailed Description
The investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine. For this purpose patients with the need of a carotid endarterectomy (CEA) will be included and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group until a patient number of 45 in each group is achieved. The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured at 6 time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
carotid endarterectomy, cardiac output, trans-cranial Doppler, CEA, regional anesthesia, general anesthesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia (RA)
Arm Type
Other
Arm Description
Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')
Arm Title
General anesthesia (GA)
Arm Type
Other
Arm Description
General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia
Intervention Description
Regional anesthesia
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia
Intervention Type
Device
Intervention Name(s)
Transcranial Doppler ultrasonography
Intervention Description
6x for 4 hours
Intervention Type
Procedure
Intervention Name(s)
blood gas analysis
Intervention Description
6 x 3 ml blood withdrawal (18 ml) within 4 hours
Intervention Type
Procedure
Intervention Name(s)
invasive arterial blood pressure measurement
Intervention Description
before operation, 8 hours, as done in clinical routine
Intervention Type
Procedure
Intervention Name(s)
arterial blood gas measurement
Intervention Description
perioperative, 4-6 times within 8 hours, as done in clinical routine
Intervention Type
Behavioral
Intervention Name(s)
Neurological Control
Intervention Description
perioperative, 2-3 days, as done in clinical routine
Intervention Type
Behavioral
Intervention Name(s)
NIRS monitoring
Intervention Description
perioperative, for 5 hours, as done in clinical routine
Intervention Type
Device
Intervention Name(s)
oxygen supply (not invasive 'Vigileo')
Intervention Description
perioperative for 5 hours, as done in clinical routine
Primary Outcome Measure Information:
Title
Influence of anesthetic technique on cardiac output during carotid endarterectomy.
Description
Number of participants: 90 patients Unit of measure: Cardiac index (l/m2) Cardiac output will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Secondary Outcome Measure Information:
Title
Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.
Description
Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Other Pre-specified Outcome Measures:
Title
Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.
Description
Number of participants: 90 patients Unit of measure: blood flow, volume and absolute tissue saturation Near infrared spectroscopy will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Title
Influence of anesthetic technique on blood pressure during carotid endarterectomy.
Description
Number of participants: 90 patients Unit of measure: blood pressure in mmHg Blood pressure will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Title
Percentage of participants with death.
Time Frame
Up to 6 months
Title
Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Percentage of participants with myocardial infarction.
Time Frame
Up to 6 months
Title
Percentage of participants with stroke.
Time Frame
Up to 6 months
Title
Influence of anesthetic technique on heart rate during carotid endarterectomy
Description
Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit Number of participants: 90 patients Unit of measure: beats per minute (bpm) Heart rate will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Title
Influence of anesthetic technique on blood gas analysis during carotid endarterectomy
Description
Number of participants: 90 patients Unit of measure: arterial oxygen tension (PaO2) Blood pressure will be measured and compared at the following time points: T0 Baseline (after insertion of an arterial line) T1 After induction of anesthesia, but before surgical start T2 Two minutes after clamping the carotid artery T3 Two minutes after shunt insertation of the carotid artery T4 After reperfusion T5 After completion of the skin suture
Time Frame
Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Elective carotid endarterectomy Signed informed consent Exclusion Criteria: Age under 18 years Missing signed informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinna Velik-Salchner, PrivDoz.Dr.
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

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Cardiac Output and Duplex Sonography in Carotid Endarterectomy

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