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The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)
Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypocapnic group | Placebo Comparator | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. |
|
| Normocapnic group | Active Comparator | Patients will be ventilated to an ETCO2 of 40-42 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypocapnic group | Other | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cerebral Desaturation Events | Cerebral desaturation events were measured with near-infrared spectroscopy | Intraoperative-first 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Nausea and Vomiting | Assessed by recovery nurses | Postanesthesia care unit-first 2 hours |
| Postanesthesia Care Unit Length of Stay (Total Time) | Approximately 5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn S. Murphy, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24860157 | Derived | Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Levin SD, Koh JL, Parikh KN, Patel SS. Effect of ventilation on cerebral oxygenation in patients undergoing surgery in the beach chair position: a randomized controlled trial. Br J Anaesth. 2014 Oct;113(4):618-27. doi: 10.1093/bja/aeu109. Epub 2014 May 23. |
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All enrolled participants completed the study, and complete data was collected on all subjects.
A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypocapnic Group | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. |
| FG001 | Normocapnic Group | Patients will be ventilated to an ETCO2 of 40-42 mm Hg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants was determined by performing a sample size calculation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypocapnic Group | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. |
| BG001 | Normocapnic Group | Patients will be ventilated to an ETCO2 of 40-42 mm Hg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Cerebral Desaturation Events | Cerebral desaturation events were measured with near-infrared spectroscopy | Posted | Number | number of events | Intraoperative-first 2 hours |
|
|
Until the time of hospital discharge
Patients were followed until hospital discharge
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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 | Hypocapnic Group | Patients will be ventilated to an ETCO2 of 30-32 mm Hg. |
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There were no technical limitations to the trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Murphy, MD, Director of Clinical Research | NorthShore University HealthSystem | 847-570-2760 | gmurphy@northshore.org |
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| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Normocapnic group |
| Other |
Patients will be ventilated to an ETCO2 of 40-42 mm Hg |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Patients Experiencing Nausea and Vomiting | Assessed by recovery nurses | Posted | Number | participants | Postanesthesia care unit-first 2 hours |
|
|
|
| Secondary | Postanesthesia Care Unit Length of Stay (Total Time) | Posted | Median | Full Range | minutes | Approximately 5 hours |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Normocapnic Group | Patients will be ventilated to an ETCO2 of 40-42 mm Hg | 0 | 34 | 0 | 34 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |