StrokeNCT01535274
Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position
A study testing Inspired oxygen fraction / end tidal carbon dioxide in people with Stroke, run by University of Michigan at 1 site in United States.
Trial summary
The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Inspired oxygen fraction / end tidal carbon dioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block
Who cannot join
- refusal to give consent
- ineligible for interscalene block
- history of cardiovascular disease
- history of cerebrovascular disease
- hypertension
- respiratory failure
- non-English speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Basic Ventilation Strategies and Anesthetic Techniques on Cerebral Oxygenation in the Beach Chair Position
The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. In the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.
Read the detailed description
This is a prospective cohort study with randomized nested design. Patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. Statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.
- Conditions
- Stroke
- Being tested
- Inspired oxygen fraction / end tidal carbon dioxide
- Keywords
- Cerebral oxygenation, Beach chair position, General anesthetic technique, Inspired oxygen fraction, End tidal carbon dioxide
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspired oxygen fraction / end tidal carbon dioxideOther
Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
- FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
- FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
- FIO2 100%, PETCO2 30mmHg - beach chair position.
- FIO2 100%, PETCO2 45mmHg - beach chair position.
- FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Receives: Other: Inspired oxygen fraction / end tidal carbon dioxide |
| Propofol | Experimental | Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Receives: Other: Inspired oxygen fraction / end tidal carbon dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point.
Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
With each set point, the value shown is the absolute change from baseline.
Measured: duration of surgery, generally no more than 90 minutes total
Regional Cerebral Oxygenation (rSO2) Values
Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice.
Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
Measured: duration of surgery, generally no more than 90 minutes total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Picton, University of Michigan
- Investigators
- Paul Picton, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535274
- Sponsor's protocol ID
- HUM00049747
- Status last verified
- Apr 2022
- First submitted
- 9 Feb 2012
- Last updated
- 6 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Picton P, Dering A, Miller B, Shanks A, Mashour GA. The influence of basic ventilation strategies and anesthetic techniques on cerebral oxygenation in the beach chair position: study protocol. BMC Anesthesiol. 2012 Sep 20;12:23. doi: 10.1186/1471-2253-12-23.
PubMed 22994896
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Basic Ventilation Strategies and Anesthetic Techniques on Cerebral Oxygenation in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT01535274
- Acronym / sponsor ID
- HUM00049747
- Conditions
- Stroke
- Keywords
- Cerebral oxygenation, Beach chair position, General anesthetic technique, Inspired oxygen fraction, End tidal carbon dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 6 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. In the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.
Detailed description
This is a prospective cohort study with randomized nested design. Patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. Statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Other: Inspired oxygen fraction / end tidal carbon dioxidePatients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. |
| Propofol | Experimental | Other: Inspired oxygen fraction / end tidal carbon dioxidePatients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block
Key exclusion criteria (7 listed)
- refusal to give consent
- ineligible for interscalene block
- history of cardiovascular disease
- history of cerebrovascular disease
- hypertension
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 |
|---|---|---|
| Inspired oxygen fraction / end tidal carbon dioxideFollowing induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve: 1. FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. 2. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. 3. FIO2 100%, PETCO2 30mmHg - beach chair position. 4. FIO2 100%, PETCO2 45mmHg - beach chair position. 5. FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. | Other | Desflurane, Propofol |
Primary outcome
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy
Time frame: duration of surgery, generally no more than 90 minutes total
rSO2 will be recorded as a "snap shot." A mean value from right and left sides will be calculated for each patient at each study point. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. With each set point, the value shown is the absolute change from baseline.
Regional Cerebral Oxygenation (rSO2) Values
Time frame: duration of surgery, generally no more than 90 minutes total
Regional cerebral oxygenation (rSO2) values at the set ventilatory points of the study for each anesthetic choice. Set Point 1: FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position. Set Point 2: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position. Set Point 3: FIO2 100%, PETCO2 30mmHg - beach chair position. Set Point 4: FIO2 100%, PETCO2 45mmHg - beach chair position. Set Point 5: FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22994896Picton P, Dering A, Miller B, Shanks A, Mashour GA. The influence of basic ventilation strategies and anesthetic techniques on cerebral oxygenation in the beach chair position: study protocol. BMC Anesthesiol. 2012 Sep 20;12:23. doi: 10.1186/1471-2253-12-23.
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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.
Paul Picton, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspired oxygen fraction / end tidal carbon dioxide in people with Stroke, run by University of Michigan at 1 site in United States.
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 7 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 6 Apr 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Regional Cerebral Oxygenation (rSO2) Before and 5 Minutes After Each Change in Ventilation Strategy (time frame: duration of surgery, generally no more than 90 minutes total). The study lists 2 primary outcomes in all. 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 NCT01535274, 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 6 Apr 2022.