Effect of Angulus on Patient-elevation Compliance
Primary Purpose
Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angulus
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator Adverse Event
Eligibility 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
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Feedback
No Feedback
Arm 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.
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Outcomes
Primary Outcome Measures
Compliance to Head of Bed Elevation to 30 Degree or More.
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.
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.
As measured by continuous variable
Full Information
NCT ID
NCT03496220
First Posted
April 2, 2018
Last Updated
December 21, 2020
Sponsor
Angulus, LLC
Collaborators
Albert Einstein College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03496220
Brief Title
Effect of Angulus on Patient-elevation Compliance
Official Title
Measuring the Effect of Angulus on Patient-elevation Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angulus, LLC
Collaborators
Albert Einstein College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia, Recumbency, Head-of-bed
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Clustered randomized cross over trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback
Arm Type
Experimental
Arm 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.
Arm Title
No Feedback
Arm Type
Other
Arm Description
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Intervention Type
Device
Intervention Name(s)
Angulus
Intervention Description
Feedback on patient recumbency
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Gong, MD
Organizational Affiliation
Einstein College of Medicine, Division of Critical Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Angulus on Patient-elevation Compliance
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