Cerebral Ischemia
Conditions
Keywords
Cerebral desaturation events, Cerebral oximetry, Beach chair position
Brief summary
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)
Detailed description
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.
Interventions
OTHERHypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
OTHERNormocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cerebral Desaturation Events | Intraoperative-first 2 hours | Cerebral desaturation events were measured with near-infrared spectroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Experiencing Nausea and Vomiting | Postanesthesia care unit-first 2 hours | Assessed by recovery nurses |
| Postanesthesia Care Unit Length of Stay (Total Time) | Approximately 5 hours | — |
Countries
United States
Participant flow
Recruitment details
A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.
Pre-assignment details
All enrolled participants completed the study, and complete data was collected on all subjects.
Participants by arm
| Arm | Count |
|---|---|
| Hypocapnic Group Patients will be ventilated to an ETCO2 of 30-32 mm Hg. | 36 |
| Normocapnic Group Patients will be ventilated to an ETCO2 of 40-42 mm Hg | 34 |
| Total | 70 |
Baseline characteristics
| Characteristic | Normocapnic Group | Hypocapnic Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 31 Participants | 61 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 12.4 | 52.3 years STANDARD_DEVIATION 13.8 | 53.3 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 34 participants | 36 participants | 70 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Incidence of Cerebral Desaturation Events
Cerebral desaturation events were measured with near-infrared spectroscopy
Time frame: Intraoperative-first 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypocapnic Group | Incidence of Cerebral Desaturation Events | 19 number of events |
| Normocapnic Group | Incidence of Cerebral Desaturation Events | 3 number of events |
Secondary
Number of Patients Experiencing Nausea and Vomiting
Assessed by recovery nurses
Time frame: Postanesthesia care unit-first 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypocapnic Group | Number of Patients Experiencing Nausea and Vomiting | 12 participants |
| Normocapnic Group | Number of Patients Experiencing Nausea and Vomiting | 3 participants |
Secondary
Postanesthesia Care Unit Length of Stay (Total Time)
Time frame: Approximately 5 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypocapnic Group | Postanesthesia Care Unit Length of Stay (Total Time) | 81.5 minutes |
| Normocapnic Group | Postanesthesia Care Unit Length of Stay (Total Time) | 69 minutes |