Impaired Oxygen DeliveryNCT02605005
The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia
An observational study of Impaired Oxygen Delivery and Cerebral Hypoxia, run by Osijek University Hospital.
Trial summary
The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Oxygen Delivery, Cerebral Hypoxia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jan 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients for elective arthroscopy of the shoulder
Who may be able to join
- Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. -
Who cannot join
- The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.
About this study
The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.
Read the detailed description
The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.
- Conditions
- Impaired Oxygen Delivery, Cerebral Hypoxia
- Keywords
- interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GA | general anesthesia | |
| ISB | interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in arterial pressure from baseline
Measured: baseline, during the operation, one hour after the operation
Secondary outcomes (1)
changes in regional cerebral oxygen saturation from baseline
Measured: baseline, during the operation, one hour after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startDec 2013
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Oxygen DeliveryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605005
- Sponsor's protocol ID
- 25-1:5484-3/2013.
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia
- ClinicalTrials.gov ID
- NCT02605005
- Acronym / sponsor ID
- 25-1:5484-3/2013.
- Conditions
- Impaired Oxygen Delivery, Cerebral Hypoxia
- Keywords
- interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 16 Nov 2015 (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.
The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.
Detailed description
The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA | – | –general anesthesia |
| ISB | – | –interscalene block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients for elective arthroscopy of the shoulder
Key inclusion criteria (1 listed)
- Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. -
Key exclusion criteria (1 listed)
- The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in arterial pressure from baseline
Time frame: baseline, during the operation, one hour after the operation
1 secondary outcome
changes in regional cerebral oxygen saturation from baseline
Time frame: baseline, during the operation, one hour after the operation
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 16 Nov 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Oxygen Delivery and Cerebral Hypoxia, run by Osijek University Hospital.
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 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
changes in arterial pressure from baseline (time frame: baseline, during the operation, one hour after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2015.