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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane | Experimental | Patients will receive general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. |
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| Propofol | Experimental | Patients will receive total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspired oxygen fraction / end tidal carbon dioxide | Other | Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | duration of surgery, generally no more than 90 minutes total |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Picton, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22994896 | Derived | 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. |
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Ten potential participants were excluded for not meeting inclusion criteria, declination to participate, and other reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
| FG001 | Desflurane | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 29 participants were initially randomized to receive Desflurane treatment, one misallocated to the Propofol arm and received Propofol treatment, and is included in the propofol arm for baseline measure for that reason.
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here. | Posted | Mean | Standard Deviation | Percent oxygen saturation | duration of surgery, generally no more than 90 minutes total |
|
During the time of surgery - not more than 90 minutes
Study team used a non-systematic approach for collecting adverse event information, reliant on patient self-reporting and study team observation during treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Picton | University of Michigan | 734-936-4280 | ppicton@umich.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| BG001 | Desflurane | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Propofol |
Patients received total intravenous general anesthesia (TIVA) with propofol. Both have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
| OG001 | Desflurane | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
|
|
|
| Primary | 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. | Of the 29 participants initially randomized to receive desflurane treatment, one participant initially randomized to the desflurane arm was misallocated to the propofol arm and received propofol treatment, so is included in the propofol arm here. | Posted | Mean | Standard Deviation | Percentage cerebral oxygen saturation | duration of surgery, generally no more than 90 minutes total |
|
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|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Desflurane | Patients received general anesthesia with desflurane. Both arms have rSO2 measured and undergo identical changes in ventilation strategy. Inspired oxygen fraction / end tidal carbon dioxide: Following induction of anesthesia, FIO2 and minute ventilation was sequentially adjusted to achieve:
| 0 | 27 | 0 | 27 | 0 | 27 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Set Point 3: Fio2 1.0 Petco2 30 mmHg |
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| Set Point 4: Fio2 1.0 Petco2 45 mmHg |
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| Set Point 5: Fio2 0.3 Petco2 30 mmHg |
|