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NCT Number: NCT02991976

Oxygen Concentration and 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.

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Key information

Conditions

Hypoxia-Ischemia, Brain Arterial Occlusive Diseases Artery Stenosis, Carotid Brain Diseases Brain Ischemia Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Ischemia, Vertebral Artery Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases Vertebrobasilar Insufficiency

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osijek Hospital University

Osijek, County of Osijek-Baranja, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen concentration

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2016
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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