Effect of Angulus on Patient-elevation Compliance

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.
Brief Title
Effect of Angulus on Patient-elevation Compliance
Completion Date
Completion Date Type
Actual
Conditions
Ventilator Adverse Event
Ventilator Associated Pneumonia
Hospital Acquired Condition
Hospital-acquired Pneumonia
Recumbency
Head-of-bed
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
Inclusion Criteria
Inclusion Criteria:

* Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
* Age between 18 and 75 years

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT03496220
Org Class
Industry
Org Full Name
Angulus, LLC
Org Study Id
001
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Measuring the Effect of Angulus on Patient-elevation Compliance
Primary Outcomes
Outcome Description
Measured as a continuous variable between 0% and 100% compliance.
Outcome Measure
Compliance to Head of Bed Elevation to 30 Degree or More.
Outcome Time Frame
3 months
Secondary Ids
Secondary Id
1R43HL131177-01A1
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michelle Gong
Investigator Email
mgong@montefiore.org
Investigator Phone
718-920-5464