Trial Outcomes & Findings for Compression Stocking Use in Shoulder Arthroscopy in Beach Chair (NCT NCT01996813)
NCT ID: NCT01996813
Last Updated: 2018-08-31
Results Overview
The prevalence of a cerebral desaturation event is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.
COMPLETED
NA
23 participants
Assessed intraoperatively, an average of 114 minutes
2018-08-31
Participant Flow
For the prospective case cohort, 23 participants were recruited from December 2013 through May 2014 (6 months) from a tertiary care practice. The remaining 24 participants were historical control participants
Participant milestones
| Measure |
Prospective Case
Patients with a BMI of 30 kg/m\^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
|
Historical Control
Patients with a BMI of 30 kg/m\^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compression Stocking Use in Shoulder Arthroscopy in Beach Chair
Baseline characteristics by cohort
| Measure |
Historical Control
n=24 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
|
Prospective Case
n=23 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.33 years
STANDARD_DEVIATION 11.53 • n=99 Participants
|
52.96 years
STANDARD_DEVIATION 10.82 • n=107 Participants
|
53.15 years
STANDARD_DEVIATION 11.07 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Body Mass Index
|
35.00 kg/m^2
n=99 Participants
|
33.40 kg/m^2
n=107 Participants
|
34.30 kg/m^2
n=206 Participants
|
|
Comorbid Diabetes
No
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Comorbid Diabetes
Yes
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Comorbid Peripheral Vascular Disease
No
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Comorbid Peripheral Vascular Disease
Yes
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Comorbid Hypertension
No
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Comorbid Hypertension
Yes
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Comorbid Obstructive Sleep Apnea
No
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Comorbid Obstructive Sleep Apnea
Yes
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Comorbid Coronary Artery Disease
No
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Comorbid Coronary Artery Disease
Yes
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Comorbid Chronic Obstructive Pulmonary Disease
No
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Comorbid Chronic Obstructive Pulmonary Disease
Yes
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Smoker
No
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Smoker
Yes
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Technique used to secure the airway
Endotracheal Tube
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Technique used to secure the airway
Laryngeal Mask Airway
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed intraoperatively, an average of 114 minutesPopulation: The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.
The prevalence of a cerebral desaturation event is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.
Outcome measures
| Measure |
Historical Control
n=24 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
|
Prospective Case
n=23 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
|
|---|---|---|
|
Cerebral Desaturation Event
No Cerebral Desaturation Event
|
17 Participants
|
22 Participants
|
|
Cerebral Desaturation Event
Cerebral desaturation event
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of surgeryPopulation: The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.
The length of operation time (in minutes) is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.
Outcome measures
| Measure |
Historical Control
n=24 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent elective shoulder arthroscopy in the beach-chair position and were monitored intraoperatively using near-infrared spectroscopy but without wearing compression stockings.
|
Prospective Case
n=23 Participants
Patients with a BMI of 30 kg/m\^2 or greater who underwent shoulder arthroscopy in the beach chair position and were monitored intraoperatively using near-infrared spectroscopy while wearing thigh-high compression stockings.
|
|---|---|---|
|
Operation Time
|
94.08 Minutes
Standard Deviation 15.47
|
134.40 Minutes
Standard Deviation 44.44
|
Adverse Events
Historical Control
Prospective Case
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place