Oxygen Concentration and Recovery After Carotid Endarterectomy

September 21, 2017 updated by: Vedran Gašić, MD, Osijek University Hospital

Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy

This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High inspired oxygen concentration may reduce brain hypoxia in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. However, there are some studies suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. This study was performed to measure the influence of fraction of inspired oxygen (FiO2) on the regional tissue oxygenation in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for area under curve (AUC) calculations. A bispectral index and invasive blood pressure monitoring were used in all patients.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • 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

  • Croatia
    • Osjecko - baranjska
      • Osijek, Osjecko - baranjska, Croatia, 31000
        • Osijek Hospital University

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

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient undergoing surgery (carotid endarterectomy)

Exclusion Criteria:

  • decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 35% O2
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
Procedure: Oxygen concentration
Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)
Active Comparator: 100% O2
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
Procedure: Oxygen concentration
Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under curve of regional cerebral oxygen saturation (rSO2) curve
Time Frame: During surgery

Intraoperative high oxygen concentrations may reduce intensity of tissue hypoxic episodes during carotid endarterectomy in total intravenous anesthesia (TIVA).

The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for Area under curve (AUC) calculations. Data were analyzed using two sided T-test and Fisher exact test. A P<0.05 was considered as statistically significant Postoperative follow up in large patient's group is necessary to confirm its impact on patients' outcome.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early neurologic recovery, TIA or brain ischemia
Time Frame: Till 7 days after surgery
Postoperative patient follow up by clinical signs or CT scan confirmation
Till 7 days after surgery
Intensive Care Unit admission, Death
Time Frame: Till 7 days after surgery
Till 7 days after surgery

Collaborators and Investigators

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

Sponsor

Osijek University Hospital

Investigators

  • Study Director: slavica kvolik, prof., Osijek Hospital University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 21, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OsijekUH4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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