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N/A N=29 Randomized Prevention

Effect of Angulus on Patient-elevation Compliance

Ventilator Adverse Event · Ventilator Associated Pneumonia · Hospital Acquired Condition · Hospital-acquired Pneumonia · Recumbency

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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