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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Assessed intraoperatively, an average of 114 minutes

Results posted on

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

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

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=93 Participants
52.96 years
STANDARD_DEVIATION 10.82 • n=4 Participants
53.15 years
STANDARD_DEVIATION 11.07 • n=27 Participants
Sex: Female, Male
Female
8 Participants
n=93 Participants
12 Participants
n=4 Participants
20 Participants
n=27 Participants
Sex: Female, Male
Male
16 Participants
n=93 Participants
11 Participants
n=4 Participants
27 Participants
n=27 Participants
Region of Enrollment
United States
24 participants
n=93 Participants
23 participants
n=4 Participants
47 participants
n=27 Participants
Body Mass Index
35.00 kg/m^2
n=93 Participants
33.40 kg/m^2
n=4 Participants
34.30 kg/m^2
n=27 Participants
Comorbid Diabetes
No
19 Participants
n=93 Participants
19 Participants
n=4 Participants
38 Participants
n=27 Participants
Comorbid Diabetes
Yes
5 Participants
n=93 Participants
4 Participants
n=4 Participants
9 Participants
n=27 Participants
Comorbid Peripheral Vascular Disease
No
24 Participants
n=93 Participants
22 Participants
n=4 Participants
46 Participants
n=27 Participants
Comorbid Peripheral Vascular Disease
Yes
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Comorbid Hypertension
No
10 Participants
n=93 Participants
10 Participants
n=4 Participants
20 Participants
n=27 Participants
Comorbid Hypertension
Yes
14 Participants
n=93 Participants
13 Participants
n=4 Participants
27 Participants
n=27 Participants
Comorbid Obstructive Sleep Apnea
No
16 Participants
n=93 Participants
17 Participants
n=4 Participants
33 Participants
n=27 Participants
Comorbid Obstructive Sleep Apnea
Yes
8 Participants
n=93 Participants
6 Participants
n=4 Participants
14 Participants
n=27 Participants
Comorbid Coronary Artery Disease
No
21 Participants
n=93 Participants
22 Participants
n=4 Participants
43 Participants
n=27 Participants
Comorbid Coronary Artery Disease
Yes
3 Participants
n=93 Participants
1 Participants
n=4 Participants
4 Participants
n=27 Participants
Comorbid Chronic Obstructive Pulmonary Disease
No
22 Participants
n=93 Participants
22 Participants
n=4 Participants
44 Participants
n=27 Participants
Comorbid Chronic Obstructive Pulmonary Disease
Yes
2 Participants
n=93 Participants
1 Participants
n=4 Participants
3 Participants
n=27 Participants
Smoker
No
15 Participants
n=93 Participants
21 Participants
n=4 Participants
36 Participants
n=27 Participants
Smoker
Yes
9 Participants
n=93 Participants
2 Participants
n=4 Participants
11 Participants
n=27 Participants
Technique used to secure the airway
Endotracheal Tube
3 Participants
n=93 Participants
6 Participants
n=4 Participants
9 Participants
n=27 Participants
Technique used to secure the airway
Laryngeal Mask Airway
21 Participants
n=93 Participants
17 Participants
n=4 Participants
38 Participants
n=27 Participants

PRIMARY outcome

Timeframe: Assessed intraoperatively, an average of 114 minutes

Population: 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

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 surgery

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prospective Case

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas Evans, M.D.

Loyola University Medical Center

Phone: 708-216-2523

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place