An interventional study of Hypocapnic group and Normocapnic group in Cerebral Ischemia, sponsored by Endeavor Health. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Endeavor Health · Not applicable, Interventional, and Prevention
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.
353 studies on the registry are indexed under Brain Ischemia; 69 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 213 interventional studies indexed under Brain Ischemia.
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Exclusion Criteria:
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Other: Hypocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Other: Normocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Incidence of Cerebral Desaturation Events
Cerebral desaturation events were measured with near-infrared spectroscopy
Time frame: Intraoperative-first 2 hours
Number of Patients Experiencing Nausea and Vomiting
Assessed by recovery nurses
Time frame: Postanesthesia care unit-first 2 hours
Postanesthesia Care Unit Length of Stay (Total Time)
Time frame: Approximately 5 hours
A total of 70 patients presenting for elective shoulder surgery at NorthShore University HealthSystem were enrolled in the clinical trial.
| Milestone | Hypocapnic Group | Normocapnic Group |
|---|---|---|
| Started | 36 | 34 |
| Completed | 36 | 34 |
| Not completed | 0 | 0 |
Cerebral desaturation events were measured with near-infrared spectroscopy
| number of events | Hypocapnic Group | Normocapnic Group |
|---|---|---|
| Incidence of Cerebral Desaturation Events | 19 | 3 |
Assessed by recovery nurses
| participants | Hypocapnic Group | Normocapnic Group |
|---|---|---|
| Number of Patients Experiencing Nausea and Vomiting | 12 | 3 |
| minutes | Hypocapnic Group | Normocapnic Group |
|---|---|---|
| Postanesthesia Care Unit Length of Stay (Total Time) | 81.5 (23 to 267) | 69 (19 to 133) |
Collected over Until the time of hospital discharge. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hypocapnic Group | — | 0/36 (0%) | 0/36 (0%) |
| Normocapnic Group | — | 0/34 (0%) | 0/34 (0%) |
The number of participants was determined by performing a sample size calculation.
| Age, Categorical(Participants) | Hypocapnic Group | Normocapnic Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 31 | 30 | 61 |
| >=65 years | 5 | 4 | 9 |
| Age, Continuous(years) | Hypocapnic Group | Normocapnic Group | Total |
|---|---|---|---|
| Mean | 52.3 ± 13.8 | 54.7 ± 12.4 | 53.3 ± 12.8 |
| Sex: Female, Male(Participants) | Hypocapnic Group | Normocapnic Group | Total |
|---|---|---|---|
| Female | 26 | 24 | 50 |
| Male | 10 | 10 | 20 |
| Region of Enrollment(participants) | Hypocapnic Group | Normocapnic Group | Total |
|---|---|---|---|
| United States | 36 | 34 | 70 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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