Hypoxia-Ischemia, BrainNCT02991976
Oxygen Concentration and Recovery After Carotid Endarterectomy
A study testing Oxygen concentration in people with Hypoxia-Ischemia, Brain and Ischemia, Vertebral Artery, run by Osijek University Hospital at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypoxia-Ischemia, Brain, Ischemia, Vertebral Artery, Artery Stenosis, Carotid
- What is being tested?
- Oxygen concentration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- Nov 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing surgery (carotid endarterectomy)
Who cannot join
- decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Osijek Hospital University
Osijek, County of Osijek-Baranja, 31000
About this study
Official title: Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
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.
Read the 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.
- Being tested
- Oxygen concentration
- Keywords
- Normobaric hyperoxia, Cerebral oxygenation, Near-infrared spectroscopy, Carotid endarterectomy, TIVA
- Medical subject headings
- Hypoxia-Ischemia, Brain, Vertebrobasilar Insufficiency, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen concentrationProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 35% O2 | Active comparator | Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration Receives: Procedure: Oxygen concentration |
| 100% O2 | Active comparator | Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration Receives: Procedure: Oxygen concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (2)
Early neurologic recovery, TIA or brain ischemia
Postoperative patient follow up by clinical signs or CT scan confirmation
Measured: Till 7 days after surgery
Intensive Care Unit admission, Death
Measured: Till 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedran Gašić, MD, Osijek University Hospital
- Investigators
- slavica kvolik, prof., Study director, Osijek Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991976
- Sponsor's protocol ID
- OsijekUH4
- Status last verified
- Sep 2017
- First submitted
- 5 Dec 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23510092Picton 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.
PubMed 19955500Nielsen 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.
PubMed 24672486Rokamp 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.
PubMed 24611051Hojlund 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.
PubMed 22988456Wolff 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.
PubMed 23852474
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT02991976
- Acronym / sponsor ID
- OsijekUH4
- Keywords
- Normobaric hyperoxia, Cerebral oxygenation, Near-infrared spectroscopy, Carotid endarterectomy, TIVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 35% O2 | Active comparator | Procedure: Oxygen concentrationPatient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration |
| 100% O2 | Active comparator | Procedure: Oxygen concentrationPatient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing surgery (carotid endarterectomy)
Key exclusion criteria (1 listed)
- decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen concentrationShunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP) | Procedure or surgery | 100% O2, 35% O2 |
Primary outcome
Area under curve of regional cerebral oxygen saturation (rSO2) curve
Time frame: During surgery
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.
2 secondary outcomes
Early neurologic recovery, TIA or brain ischemia
Time frame: Till 7 days after surgery
Intensive Care Unit admission, Death
Time frame: Till 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 23510092Rockswold 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 publication: PubMed 19955500Picton 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 publication: PubMed 24672486Nielsen 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 publication: PubMed 24611051Rokamp 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 publication: PubMed 22988456Hojlund 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 publication: PubMed 23852474Wolff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
slavica kvolik, prof. study director
Osijek Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen concentration in people with Hypoxia-Ischemia, Brain and Ischemia, Vertebral Artery, run by Osijek University Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of regional cerebral oxygen saturation (rSO2) curve (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991976, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.