Effect of Angulus on Patient-elevation Compliance

Sponsor
Angulus, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03496220
Collaborator
Albert Einstein College of Medicine (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), Montefiore Medical Center (Other)
90
1
2
2.7
33.4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Clustered randomized cross over trialClustered randomized cross over trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Measuring the Effect of Angulus on Patient-elevation Compliance
Actual Study Start Date :
Jul 10, 2018
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

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

  1. 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

  1. 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

  2. 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

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Angulus, LLC
ClinicalTrials.gov Identifier:
NCT03496220
Other Study ID Numbers:
  • 001
  • 1R43HL131177-01A1
First Posted:
Apr 12, 2018
Last Update Posted:
Jan 19, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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
3. Secondary Outcome
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

[Not Specified]

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
Email perry@angulus.us
Responsible Party:
Angulus, LLC
ClinicalTrials.gov Identifier:
NCT03496220
Other Study ID Numbers:
  • 001
  • 1R43HL131177-01A1
First Posted:
Apr 12, 2018
Last Update Posted:
Jan 19, 2021
Last Verified:
Dec 1, 2020