Clinical Trial: Oxygen Concentration and Recovery After Carotid Endarterectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: Osijek University Hospital

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Osijek University Hospital

Dates:
Date Received: December 5, 2016
Date Started: November 2016
Date Completion: August 2017
Last Updated: December 9, 2016
Last Verified: December 2016