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Effect of Angulus on Patient-elevation Compliance

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ClinicalTrials.gov Identifier: NCT03496220
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Montefiore Medical Center
Information provided by (Responsible Party):
Angulus, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Ventilator Adverse Event
Ventilator Associated Pneumonia
Hospital Acquired Condition
Hospital-acquired Pneumonia
Recumbency
Head-of-bed
Intervention Device: Angulus
Enrollment 90
Recruitment Details  
Pre-assignment Details  
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
Hide 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: Second Intervention
Started 17 9 11
Completed 17 9 11
Not Completed 0 0 0
Period Title: Third Intervention
Started 11 8 5
Completed 11 8 5
Not Completed 0 0 0
Arm/Group Title Feedback No Feedback Total
Hide 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 Number of Baseline Participants 49 41 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 41 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  65.3%
31
  75.6%
63
  70.0%
>=65 years
17
  34.7%
10
  24.4%
27
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 41 participants 90 participants
56.7  (12.7) 58.7  (10.1) 57.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 41 participants 90 participants
Female
16
  32.7%
19
  46.3%
35
  38.9%
Male
33
  67.3%
22
  53.7%
55
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 41 participants 90 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 41 participants 90 participants
American Indian or Alaska Native
0
   0.0%
1
   2.4%
1
   1.1%
Asian
1
   2.0%
0
   0.0%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
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%
0
   0.0%
Unknown or Not Reported
19
  38.8%
16
  39.0%
35
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 41 participants 90 participants
49 41 90
1.Primary Outcome
Title Compliance to Head of Bed Elevation to 30 Degree or More.
Hide Description Measured as a continuous variable between 0% and 100% compliance.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Time spent in evidence based recumbency range comparison.
Arm/Group Title Feedback No Feedback
Hide 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

Overall Number of Participants Analyzed 49 41
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description As measured as categorical variable: incidence of decubitus ulcer
Time Frame 3 months
Outcome Measure Data Not Reported
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.
Hide Description As measured by continuous variable
Time Frame 3 months
Outcome Measure Data Not Reported
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
Hide 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 (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/41 (0.00%) 
Hide Serious Adverse Events
Feedback No Feedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/41 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Feedback No Feedback
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/41 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Perry Dubin
Organization: Angulus
Phone: ‪(917) 426-5911‬
EMail: perry@angulus.us
Layout table for additonal information
Responsible Party: Angulus, LLC
ClinicalTrials.gov Identifier: NCT03496220    
Other Study ID Numbers: 001
1R43HL131177-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 2, 2018
First Posted: April 12, 2018
Results First Submitted: August 4, 2020
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021