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

Interventions: Device: Angulus

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

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

Arm && Interventions

Group	Intervention	Description
Feedback	Angulus	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.
No Feedback	Angulus	The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.

Primary Outcome Measures