Oxygen Concentration and Recovery After Carotid Endarterectomy
Primary Purpose
Hypoxia-Ischemia, Brain, Ischemia, Vertebral Artery, Artery Stenosis, Carotid
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Oxygen concentration
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia-Ischemia, Brain focused on measuring Normobaric hyperoxia, Cerebral oxygenation, Near-infrared spectroscopy, Carotid endarterectomy, TIVA
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
Sites / Locations
- Osijek Hospital University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
35% O2
100% O2
Arm Description
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
Outcomes
Primary Outcome Measures
Area under curve of regional cerebral oxygen saturation (rSO2) curve
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
Early neurologic recovery, TIA or brain ischemia
Postoperative patient follow up by clinical signs or CT scan confirmation
Intensive Care Unit admission, Death
Full Information
NCT ID
NCT02991976
First Posted
December 5, 2016
Last Updated
September 21, 2017
Sponsor
Osijek University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02991976
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osijek University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia-Ischemia, Brain, Ischemia, Vertebral Artery, Artery Stenosis, Carotid
Keywords
Normobaric hyperoxia, Cerebral oxygenation, Near-infrared spectroscopy, Carotid endarterectomy, TIVA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
35% O2
Arm Type
Active Comparator
Arm Description
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
Arm Title
100% O2
Arm Type
Active Comparator
Arm Description
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
Intervention Type
Procedure
Intervention Name(s)
Oxygen concentration
Intervention 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)
Primary Outcome Measure Information:
Title
Area under curve of regional cerebral oxygen saturation (rSO2) curve
Description
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.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Early neurologic recovery, TIA or brain ischemia
Description
Postoperative patient follow up by clinical signs or CT scan confirmation
Time Frame
Till 7 days after surgery
Title
Intensive Care Unit admission, Death
Time Frame
Till 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
slavica kvolik, prof.
Organizational Affiliation
Osijek Hospital University
Official's Role
Study Director
Facility Information:
Facility Name
Osijek Hospital University
City
Osijek
State/Province
Osjecko - baranjska
ZIP/Postal Code
31000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23510092
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.
Results Reference
background
PubMed Identifier
19955500
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.
Results Reference
result
PubMed Identifier
24672486
Citation
Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.
Results Reference
result
PubMed Identifier
24611051
Citation
Rokamp KZ, Secher NH, Eiberg J, Lonn L, Nielsen HB. O2 supplementation to secure the near-infrared spectroscopy determined brain and muscle oxygenation in vascular surgical patients: a presentation of 100 cases. Front Physiol. 2014 Feb 25;5:66. doi: 10.3389/fphys.2014.00066. eCollection 2014.
Results Reference
result
PubMed Identifier
22988456
Citation
Hojlund J, Sandmand M, Sonne M, Mantoni T, Jorgensen HL, Belhage B, van Lieshout JJ, Pott FC. Effect of head rotation on cerebral blood velocity in the prone position. Anesthesiol Res Pract. 2012;2012:647258. doi: 10.1155/2012/647258. Epub 2012 Sep 5.
Results Reference
result
PubMed Identifier
23852474
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.
Results Reference
result
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Oxygen Concentration and Recovery After Carotid Endarterectomy
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