Oxygen Concentration and Recovery After Carotid Endarterectomy

NCT02991976 | Completed

• 1 other identifier: OsijekUH4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Normobaric hyperoxia; Cerebral oxygenation; Near-infrared spectroscopy; Carotid endarterectomy; TIVA

Outcome Measures

Primary Outcomes (1)

• 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.

  During surgery

Secondary Outcomes (2)

• Early neurologic recovery, TIA or brain ischemia

  Till 7 days after surgery

• Intensive Care Unit admission, Death

  Till 7 days after surgery

Study Arms (2)

35% O2

ACTIVE COMPARATOR

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

Procedure: Oxygen concentration

100% O2

ACTIVE COMPARATOR

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

Procedure: Oxygen concentration

Interventions

Oxygen concentration PROCEDURE

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)

100% O2; 35% O2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient undergoing surgery (carotid endarterectomy)

You may not qualify if:

• decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

Osijek Hospital University

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Related Publications (6)

• 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.

  PMID: 23510092 BACKGROUND

• 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.

  PMID: 19955500 RESULT

• 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.

  PMID: 24672486 RESULT

• 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.

  PMID: 24611051 RESULT

• 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.

  PMID: 22988456 RESULT

• 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.

  PMID: 23852474 RESULT

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Vertebrobasilar Insufficiency; Carotid Stenosis

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• slavica kvolik, prof.

  Osijek Hospital University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vedran Gasic, M.D.

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 14, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

CR (1)