N/A
N=29
Effect of Angulus on Patient-elevation Compliance
Ventilator Adverse Event · Ventilator Associated Pneumonia · Hospital Acquired Condition · Hospital-acquired Pneumonia · Recumbency
Bottom Line
View on ClinicalTrials.gov: NCT03496220 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Compliance to Head of Bed Elevation to 30 Degree or More. — 37.3; 32.4 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Angulus (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Angulus, LLC
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance to Head of Bed Elevation to 30 Degree or More. |
37.3; 32.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03496220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.