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Effect of the Built Operating Room Environment on Patient Outcome

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ClinicalTrials.gov Identifier: NCT03037905
Recruitment Status : Completed
First Posted : January 31, 2017
Results First Posted : November 22, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
STERIS Corporation
Information provided by (Responsible Party):
Christian Burchill, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anxiety
Intervention Device: SignatureSuite OR Integration System by STERIS Corporation
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description

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.

Patients who's surgeon has been randomized into the standard operating room.
Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title SignatureSuite OR Standard OR Total
Hide Arm/Group Description

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.

Patients who's surgeon has been randomized into the standard operating room. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
Thyroid surgery cases
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
51.7  (14.3) 53.3  (14.3) 52.5  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
41
  82.0%
43
  86.0%
84
  84.0%
Male
9
  18.0%
7
  14.0%
16
  16.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Hispanic or Latino
0
   0.0%
1
   2.0%
1
   1.0%
Not Hispanic or Latino
49
  98.0%
48
  96.0%
97
  97.0%
Unknown or Not Reported
1
   2.0%
1
   2.0%
2
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.0%
0
   0.0%
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.0%
12
  24.0%
15
  15.0%
White
41
  82.0%
36
  72.0%
77
  77.0%
More than one race
1
   2.0%
2
   4.0%
3
   3.0%
Unknown or Not Reported
3
   6.0%
0
   0.0%
3
   3.0%
Surgical site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Parathyroid
16
  32.0%
22
  44.0%
38
  38.0%
Thyroid
34
  68.0%
28
  56.0%
62
  62.0%
Kindler Preoperative Anxiety Scale Total Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
29.8
(15.8 to 55.2)
26.6
(8.6 to 44.1)
28.9
(10.3 to 47.9)
[1]
Measure Description: The Kindler preoperative anxiety scale quantifies 10 factors that cause preoperative anxiety. Each factor 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 on each factor. 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. The average of the scores represents the total preoperative anxiety score.
Past medical history diagnosis groups  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
cardiovascular/respiratory 13 19 32
Other 15 19 34
endocrine 49 48 97
gastrointestinal/genitourinary 20 18 38
neuromuscular 16 25 41
Preoperative anxiety visual analog scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 50 participants 100 participants
36.3  (27.9) 32.0  (28.9) 34.13  (28.4)
[1]
Measure Description: The preoperative anxiety scale quantifies preoperative 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 preoperative 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.
Preoperative systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 50 participants 50 participants 100 participants
137.50  (17.4) 142.6  (19.8) 140.0  (18.7)
Preoperative heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 50 participants 50 participants 100 participants
77.9  (12.7) 78.8  (15.3) 78.4  (14.0)
1.Primary Outcome
Title Change (Difference) in Anxiety
Hide Description 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.
Time Frame Pre-operatively to post-operatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
thyroid and/or parathyroid surgery patients
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description:

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.

Patients who's surgeon has been randomized into the standard operating room.
Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-24.4
(-31.7 to -17.0)
-17.6
(-25.1 to -10.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SignatureSuite OR, Standard OR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.7
Confidence Interval (2-Sided) 95%
-17.1 to 3.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures
Hide Description 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
Time Frame Pre-operative to post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients undergoing thyroid and/or parathyroid surgery
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description:

The intervention is exposure to the operating room environment created by the device SignatureSuite OR Integration System by STERIS Corporation.

SignatureSuite OR Integration System by STERIS Corporation: SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.

Standard operating room without SignatureSuite OR Integration System by STERIS Corporation.
Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-4.2
(-9.8 to 1.4)
-6.4
(-12.3 to -0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SignatureSuite OR, Standard OR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-5.9 to 10.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates
Hide Description 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
Time Frame Pre-operative to post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients undergoing thyroid and/or parathyroid surgery
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description:

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.

Patients who's surgeon has been randomized into the standard operating room.
Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: beats per minute
3.1
(-1.3 to 7.5)
4.1
(-0.2 to 8.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SignatureSuite OR, Standard OR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .76
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-7.0 to 5.1
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Analgesic Use
Hide Description Number of people requiring analgesia in the post-anesthesia care unit
Time Frame Postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients that have undergone thyroid and/or parathyroid surgery
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description:

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.

Patients who's surgeon has been randomized into the standard operating room.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
9
  18.0%
10
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SignatureSuite OR, Standard OR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Postoperatively until discharged from the post-anesthesia care unit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SignatureSuite OR Standard OR
Hide Arm/Group Description

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.

Patients who's surgeon has been randomized into the standard operating room.
All-Cause Mortality
SignatureSuite OR Standard OR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SignatureSuite OR Standard OR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SignatureSuite OR Standard OR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Study was conducted at one community hospital in Northeast Ohio. Study population limited to patients having thyroid or parathyroid surgery. Low dose anxiolytic given intravenously in the preoperative holding area prior to being moved to the OR.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christian N. Burchill, PhD, RN, CEN
Organization: Cleveland Clinic
Phone: 216-445-9317
Responsible Party: Christian Burchill, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03037905     History of Changes
Other Study ID Numbers: CCF15-009
First Submitted: September 11, 2016
First Posted: January 31, 2017
Results First Submitted: September 15, 2017
Results First Posted: November 22, 2017
Last Update Posted: December 19, 2017