Cardiac Output and Duplex Sonography in Carotid Endarterectomy

September 6, 2021 updated by: Priv.Doz. Dr. Corinna Velik-Salchner, Medical University Innsbruck

Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medical University Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Regional anesthesia (RA)
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')
Procedure: Regional anesthesia
Regional anesthesia
Device: Transcranial Doppler ultrasonography
6x for 4 hours
Procedure: blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
Procedure: invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
Procedure: arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
Behavioral: Neurological Control
perioperative, 2-3 days, as done in clinical routine
Behavioral: NIRS monitoring
perioperative, for 5 hours, as done in clinical routine
Device: oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
Other: General anesthesia (GA)
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')
Device: Transcranial Doppler ultrasonography
6x for 4 hours
Procedure: blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
Procedure: invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
Procedure: arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
Behavioral: Neurological Control
perioperative, 2-3 days, as done in clinical routine
Behavioral: NIRS monitoring
perioperative, for 5 hours, as done in clinical routine
Device: oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
Procedure: General anesthesia
General anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Influence of anesthetic technique on cardiac output during carotid endarterectomy.
Time Frame: 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: 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
Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.
Time Frame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

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
Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.
Time Frame: Change of cardiac output 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: 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
Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Influence of anesthetic technique on blood pressure during carotid endarterectomy.
Time Frame: Change of blood pressure, 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: 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
Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Percentage of participants with death.
Time Frame: Up to 6 months
Up to 6 months
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
Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Percentage of participants with myocardial infarction.
Time Frame: Up to 6 months
Up to 6 months
Percentage of participants with stroke.
Time Frame: Up to 6 months
Up to 6 months
Influence of anesthetic technique on heart rate during carotid endarterectomy
Time Frame: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

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
Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Influence of anesthetic technique on blood gas analysis during carotid endarterectomy
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

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
Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Corinna Velik-Salchner, PrivDoz.Dr., Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CODUCE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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