Trial Outcomes & Findings for Effect of the Built Operating Room Environment on Patient Outcome (NCT NCT03037905)
NCT ID: NCT03037905
Last Updated: 2020-07-16
Results Overview
Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine." Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Pre-operatively to post-operatively
Results posted on
2020-07-16
Participant Flow
Participant milestones
| Measure |
SignatureSuite OR
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
Patients who's surgeon has been randomized into the standard operating room.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of the Built Operating Room Environment on Patient Outcome
Baseline characteristics by cohort
| Measure |
SignatureSuite OR
n=50 Participants
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
n=50 Participants
Patients who's surgeon has been randomized into the standard operating room.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
53.3 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 14.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Surgical site
Parathyroid
|
16 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Surgical site
Thyroid
|
34 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Kindler Preoperative Anxiety Scale Total Score
|
29.8 units on a scale
n=93 Participants
|
26.6 units on a scale
n=4 Participants
|
28.9 units on a scale
n=27 Participants
|
|
Past medical history diagnosis groups
cardiovascular/respiratory
|
13 participants
n=93 Participants
|
19 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
Past medical history diagnosis groups
Other
|
15 participants
n=93 Participants
|
19 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Past medical history diagnosis groups
endocrine
|
49 participants
n=93 Participants
|
48 participants
n=4 Participants
|
97 participants
n=27 Participants
|
|
Past medical history diagnosis groups
gastrointestinal/genitourinary
|
20 participants
n=93 Participants
|
18 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Past medical history diagnosis groups
neuromuscular
|
16 participants
n=93 Participants
|
25 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Preoperative anxiety visual analog scale
|
36.3 units on a scale
STANDARD_DEVIATION 27.9 • n=93 Participants
|
32.0 units on a scale
STANDARD_DEVIATION 28.9 • n=4 Participants
|
34.13 units on a scale
STANDARD_DEVIATION 28.4 • n=27 Participants
|
|
Preoperative systolic blood pressure
|
137.50 mm Hg
STANDARD_DEVIATION 17.4 • n=93 Participants
|
142.6 mm Hg
STANDARD_DEVIATION 19.8 • n=4 Participants
|
140.0 mm Hg
STANDARD_DEVIATION 18.7 • n=27 Participants
|
|
Preoperative heart rate
|
77.9 beats per minute
STANDARD_DEVIATION 12.7 • n=93 Participants
|
78.8 beats per minute
STANDARD_DEVIATION 15.3 • n=4 Participants
|
78.4 beats per minute
STANDARD_DEVIATION 14.0 • n=27 Participants
|
PRIMARY outcome
Timeframe: Pre-operatively to post-operativelyPopulation: thyroid and/or parathyroid surgery patients
Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors "No anxiety" to "The most anxiety I can imagine." Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety.
Outcome measures
| Measure |
SignatureSuite OR
n=50 Participants
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
n=50 Participants
Patients who's surgeon has been randomized into the standard operating room.
|
|---|---|---|
|
Change (Difference) in Anxiety
|
-24.4 units on a scale
Interval -31.7 to -17.0
|
-17.6 units on a scale
Interval -25.1 to -10.2
|
SECONDARY outcome
Timeframe: Pre-operative to post-operativePopulation: Patients undergoing thyroid and/or parathyroid surgery
Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
Outcome measures
| Measure |
SignatureSuite OR
n=50 Participants
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
n=50 Participants
Patients who's surgeon has been randomized into the standard operating room.
|
|---|---|---|
|
Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
|
-4.2 mm Hg
Interval -9.8 to 1.4
|
-6.4 mm Hg
Interval -12.3 to -0.5
|
SECONDARY outcome
Timeframe: Pre-operative to post-operativePopulation: Patients undergoing thyroid and/or parathyroid surgery
Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit
Outcome measures
| Measure |
SignatureSuite OR
n=50 Participants
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
n=50 Participants
Patients who's surgeon has been randomized into the standard operating room.
|
|---|---|---|
|
Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
|
3.1 beats per minute
Interval -1.3 to 7.5
|
4.1 beats per minute
Interval -0.2 to 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: PostoperativelyPopulation: Patients that have undergone thyroid and/or parathyroid surgery
Number of people requiring analgesia in the post-anesthesia care unit
Outcome measures
| Measure |
SignatureSuite OR
n=50 Participants
Patients who's surgeon has been randomized into the SignatureSuite operating room. The intervention is the unique operating room environment created by the product.
SignatureSuite™ OR Integration System by STERIS Corporation: SignatureSuite™ OR Integration System by STERIS Corporation is a product that includes software to control the audio and visual components of the operating room in order to provide a more relaxed and calming environment for patients prior to their surgery. It automatically dims lights, plays pleasant music or sounds of nature over the in-room speakers, and provides scenes of nature on video screens stationed in viewing range of the patient. As anesthesia is administered to the patient, the system automatically adjusts the light and sound systems to come up to surgeon-preferred preset stations. The process happens in reverse as the patient emerges from general anesthesia so that they awaken in the same environment as when they arrived in the OR.
|
Standard OR
n=50 Participants
Patients who's surgeon has been randomized into the standard operating room.
|
|---|---|---|
|
Analgesic Use
|
9 Participants
|
10 Participants
|
Adverse Events
SignatureSuite OR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard OR
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place