Oxygen Concentration and Recovery After Carotid Endarterectomy

Not Applicable

Completed

• Conditions: Hypoxia-Ischemia, Brain; Artery Stenosis, Carotid; Ischemia, Vertebral Artery
• Interventions: Procedure: Oxygen concentration

• Registration Number: NCT02991976
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-14
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
35% O2	Oxygen concentration	Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
100% O2	Oxygen concentration	Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration

Primary Outcome Measures

Name	Time	Method
Area under curve of regional cerebral oxygen saturation (rSO2) curve	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

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

Trial Locations

Locations (1)

Osijek Hospital University; 🇭🇷 Osijek, Osjecko - baranjska, Croatia