Cerebral IschemiaNCT02643030
Hypercapnia During Shoulder Arthroscopy
A study testing hypercapnia and normocapnia in people with Cerebral Ischemia, run by Gachon University Gil Medical Center.
Trial summary
The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- hypercapnia and normocapnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Oct 2015
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective shoulder arthroscopic surgery
Who cannot join
- a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
About this study
Official title: The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.
Read the detailed description
The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).
- Conditions
- Cerebral Ischemia
- Being tested
- hypercapnia, normocapnia
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypercapniaBehavioural
Also called ETCO2-45
Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
normocapniaBehavioural
Also called ETCO2-35
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
| Study group | Role | What they receive |
|---|---|---|
| normocapnia | Experimental | Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg Receives: Behavioral: normocapnia |
| hypercapnia | Active comparator | Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg Receives: Behavioral: hypercapnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral oxygen saturation
Measured: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startMar 2012
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral IschemiaStudies 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
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
- Investigators
- Kyung Cheon Lee, MD, Study chair, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643030
- Sponsor's protocol ID
- GIRBA2674-2012
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
PubMed 16171668
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
- ClinicalTrials.gov ID
- NCT02643030
- Acronym / sponsor ID
- GIRBA2674-2012
- Conditions
- Cerebral Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Dec 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 purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.
Detailed description
The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normocapnia | Experimental | Behavioral: normocapniaTidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg |
| hypercapnia | Active comparator | Behavioral: hypercapniaTidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective shoulder arthroscopic surgery
Key exclusion criteria (1 listed)
- a history of age > 65 years, morbidly obesity (BMI > 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.
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 |
|---|---|---|
| hypercapniaAlso: ETCO2-45Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg | Behavioural | hypercapnia |
| normocapniaAlso: ETCO2-35Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg | Behavioural | normocapnia |
Primary outcome
Regional cerebral oxygen saturation
Time frame: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position
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 30 Dec 2015.
- Results publication: PubMed 16171668Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.
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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.
Kyung Cheon Lee, MD study chair
Gachon University Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing hypercapnia and normocapnia in people with Cerebral Ischemia, run by Gachon University Gil Medical Center.
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 30 Dec 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?
Regional cerebral oxygen saturation (time frame: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position). 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 NCT02643030, which also lists 1 linked publication.
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 30 Dec 2015.