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Oxygen Concentration and Recovery After Carotid Endarterectomy

O

Osijek University Hospital

Status

Completed

Conditions

Ischemia, Vertebral Artery
Artery Stenosis, Carotid
Hypoxia-Ischemia, Brain

Treatments

Procedure: Oxygen concentration

Study type

Interventional

Funder types

Other

Identifiers

NCT02991976
OsijekUH4

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

35% O2
Active Comparator group
Description:
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
Treatment:
Procedure: Oxygen concentration
100% O2
Active Comparator group
Description:
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
Treatment:
Procedure: Oxygen concentration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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