Effect of Angulus on Patient-elevation Compliance
Study Details
Study Description
Brief Summary
Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in critically ill patients by up to 50%, while simultaneously increasing cost of care. C
Best-practice guidelines state that positioning ventilated patients at an angle between 30-45 degrees significantly reduces the potential for VAP and other VAE to develop. While the intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB) protractor - a tool which reflects the angle of the bed, not the patient - to measure compliance. Depending upon the position and posture of the patient in the bed, a patient's elevation angle may be significantly different from the HOB angle. Critical care teams currently rely on built-in HOB protractors and digital inclinometers that measure the angle of the bed not the patient.
Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care technology. Angulus enables critical care practitioners to instantaneously understand a patient's elevation, identify when the patient is outside of the desired 30-45 degree recumbency scope, and efficiently correct the patient's orientation with immediate feedback. Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation of data.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Feedback The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. |
Device: Angulus
Feedback on patient recumbency
|
Other: No Feedback The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. |
Device: Angulus
Feedback on patient recumbency
|
Outcome Measures
Primary Outcome Measures
- Compliance to Head of Bed Elevation to 30 Degree or More. [3 months]
Measured as a continuous variable between 0% and 100% compliance.
Secondary Outcome Measures
- Frequency That Patients in the ICU Are Rotated More Than 30 Degree Within 24 Hour Days and Association With Development of Decubitus Ulcers. [3 months]
As measured as categorical variable: incidence of decubitus ulcer
- Frequency That Patients in the ICU Rotate More Than 30 Degree and Have Change in Elevation of More Than 15 Degree Within an Hour and Correlation With Agitation as Indicated by RASS. [3 months]
As measured by continuous variable
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
-
Age between 18 and 75 years
Exclusion Criteria:
-
Patients with a known allergy to the encasing materials
-
Patients who are advised to be positioned outside of the 30-45 degree scope.
-
Patients with any major chest wall abnormalities, or defects, including but not limited to:
-
post-cardiac surgical patients
-
pectus excavatum (or any congenital chest wall deformity)
-
complicated skin and soft tissue infections on the chest wall
-
heart-lung machine systems
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
Sponsors and Collaborators
- Angulus, LLC
- Albert Einstein College of Medicine
- National Heart, Lung, and Blood Institute (NHLBI)
- Montefiore Medical Center
Investigators
- Principal Investigator: Michelle Gong, MD, Einstein College of Medicine, Division of Critical Care
Study Documents (Full-Text)
More Information
Publications
None provided.- 001
- 1R43HL131177-01A1
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | ICU A Feedback First, Then no Feedback, and Feedback Last | ICU B No Feedback First, Then Feedback, and No Feedback Last | ICU C: Feedback First, Then No Feedback, and Feedback Last |
---|---|---|---|
Arm/Group Description | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period the Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency |
Period Title: First Intervention | |||
STARTED | 15 | 4 | 10 |
COMPLETED | 15 | 4 | 10 |
NOT COMPLETED | 0 | 0 | 0 |
Period Title: First Intervention | |||
STARTED | 17 | 9 | 11 |
COMPLETED | 17 | 9 | 11 |
NOT COMPLETED | 0 | 0 | 0 |
Period Title: First Intervention | |||
STARTED | 11 | 8 | 5 |
COMPLETED | 11 | 8 | 5 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Feedback | No Feedback | Total |
---|---|---|---|
Arm/Group Description | The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. Angulus: Feedback on patient recumbency | The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency | Total of all reporting groups |
Overall Participants | 49 | 41 | 90 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
32
65.3%
|
31
75.6%
|
63
70%
|
>=65 years |
17
34.7%
|
10
24.4%
|
27
30%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
56.7
(12.7)
|
58.7
(10.1)
|
57.6
(11.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
16
32.7%
|
19
46.3%
|
35
38.9%
|
Male |
33
67.3%
|
22
53.7%
|
55
61.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
18
36.7%
|
14
34.1%
|
32
35.6%
|
Not Hispanic or Latino |
31
63.3%
|
27
65.9%
|
58
64.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
1
2.4%
|
1
1.1%
|
Asian |
1
2%
|
0
0%
|
1
1.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
17
34.7%
|
14
34.1%
|
31
34.4%
|
White |
12
24.5%
|
10
24.4%
|
22
24.4%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
19
38.8%
|
16
39%
|
35
38.9%
|
Region of Enrollment (participants) [Number] | |||
United States |
49
100%
|
41
100%
|
90
100%
|
Outcome Measures
Title | Compliance to Head of Bed Elevation to 30 Degree or More. |
---|---|
Description | Measured as a continuous variable between 0% and 100% compliance. |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
Time spent in evidence based recumbency range comparison. |
Arm/Group Title | Feedback | No Feedback |
---|---|---|
Arm/Group Description | The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. Angulus: Feedback on patient recumbency | The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency |
Measure Participants | 49 | 41 |
Mean (Standard Deviation) [percentage of time] |
37.3
(26.2)
|
32.4
(29.3)
|
Title | Frequency That Patients in the ICU Are Rotated More Than 30 Degree Within 24 Hour Days and Association With Development of Decubitus Ulcers. |
---|---|
Description | As measured as categorical variable: incidence of decubitus ulcer |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Frequency That Patients in the ICU Rotate More Than 30 Degree and Have Change in Elevation of More Than 15 Degree Within an Hour and Correlation With Agitation as Indicated by RASS. |
---|---|
Description | As measured by continuous variable |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | 3 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | No adverse events were noted as a result of participation in the study. | |||
Arm/Group Title | Feedback | No Feedback | ||
Arm/Group Description | The ICU with feedback will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. Angulus: Feedback on patient recumbency | The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency | ||
All Cause Mortality |
||||
Feedback | No Feedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/49 (0%) | 0/41 (0%) | ||
Serious Adverse Events |
||||
Feedback | No Feedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/49 (0%) | 0/41 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Feedback | No Feedback | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/49 (0%) | 0/41 (0%) |
Limitations/Caveats
More Information
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 | Dr. Perry Dubin |
---|---|
Organization | Angulus |
Phone | (917) 426-5911 |
perry@angulus.us |
- 001
- 1R43HL131177-01A1