Oxygen Concentration and Recovery After Carotid Endarterectomy

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

Sponsors

Lead Sponsor: Osijek University Hospital

Source 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.

Overall Status Completed
Start Date November 2016
Completion Date August 2017
Primary Completion Date August 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Area under curve of regional cerebral oxygen saturation (rSO2) curve During surgery
Secondary Outcome
Measure Time Frame
Early neurologic recovery, TIA or brain ischemia Till 7 days after surgery
Intensive Care Unit admission, Death Till 7 days after surgery
Enrollment 80
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Oxygen concentration

Description: 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)

Eligibility

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

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
slavica kvolik, prof. Study Director Osijek Hospital University
Location
Facility: Osijek Hospital University
Location Countries

Croatia

Verification Date

September 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Osijek University Hospital

Investigator Full Name: Vedran Gašić, MD

Investigator Title: Vedran Gasic, M.D.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 35% O2

Type: Active Comparator

Description: Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration

Label: 100% O2

Type: Active Comparator

Description: Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov