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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
Osijek University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
December 5, 2016
Last Updated
September 21, 2017
Sponsor
Osijek University Hospital
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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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