Effect of Angulus on Patient-elevation Compliance

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia; Hospital Acquired Condition; Ventilator Adverse Event; Recumbency; Head-of-bed; Hospital-acquired Pneumonia

• Registration Number: NCT03496220
• Lead Sponsor: Angulus, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-07-10
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Results First Submitted: 2020-08-04
• Results First Submitted QC: 2020-12-21
• Results First Posted: 2021-01-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Compliance to Head of Bed Elevation to 30 Degree or More.	3 months	Measured as a continuous variable between 0% and 100% compliance.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States