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Oxygen Concentration and Recovery After Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT02991976
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Vedran Gašić, MD, Osijek University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypoxia-Ischemia, Brain Ischemia, Vertebral Artery Artery Stenosis, Carotid Procedure: Oxygen concentration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
Study Start Date : November 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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)




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. Intensive Care Unit admission, Death [ Time Frame: Till 7 days after surgery ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991976


Locations
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Croatia
Osijek Hospital University
Osijek, Osjecko - baranjska, Croatia, 31000
Sponsors and Collaborators
Osijek University Hospital
Investigators
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Study Director: slavica kvolik, prof. Osijek Hospital University

Publications of Results:
Other Publications:
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Responsible Party: Vedran Gašić, MD, Vedran Gasic, M.D., Osijek University Hospital
ClinicalTrials.gov Identifier: NCT02991976     History of Changes
Other Study ID Numbers: OsijekUH4
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vedran Gašić, MD, Osijek University Hospital:
Normobaric hyperoxia
Cerebral oxygenation
Near-infrared spectroscopy
Carotid endarterectomy
TIVA
Additional relevant MeSH terms:
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Brain Ischemia
Hypoxia-Ischemia, Brain
Carotid Stenosis
Vertebrobasilar Insufficiency
Ischemia
Hypoxia
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Carotid Artery Diseases
Arterial Occlusive Diseases