Clinical trial NCT02991976: Oxygen Concentration and Recovery After Carotid Endarterectomy
Official title: Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia-Ischemia, Brain
Ischemia, Vertebral Artery
Artery Stenosis, Carotid
Keywords: Normobaric hyperoxia
Cerebral oxygenation
Near-infrared spectroscopy
Carotid endarterectomy
TIVA
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Area under curve of regional cerebral oxygen saturation (rSO2) curve
timeFrame: During surgery
Secondary outcomes:
measure: Early neurologic recovery, TIA or brain ischemia
timeFrame: Till 7 days after surgery
measure: Intensive Care Unit admission, Death
timeFrame: Till 7 days after surgery
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Osijek Hospital University
state: Osjecko - baranjska
Study officials:
affiliation: Osijek Hospital University
name: slavica kvolik, prof.
role: STUDY_DIRECTOR
References:
citation: Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
citation: Picton P, Chambers J, Shanks A, Dorje P. The influence of inspired oxygen fraction and end-tidal carbon dioxide on post-cross-clamp cerebral oxygenation during carotid endarterectomy under general anesthesia. Anesth Analg. 2010 Feb 1;110(2):581-7. doi: 10.1213/ANE.0b013e3181c5f160. Epub 2009 Dec 2.
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citation: Wolff CB. Oxygen delivery: the principal role of the circulation. Adv Exp Med Biol. 2013;789:37-42. doi: 10.1007/978-1-4614-7411-1_6.