Effect of Angulus on Patient-elevation Compliance

Angulus

Status: Completed

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

Treatments: Device: Angulus

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03496220

1R43HL131177-01A1 (U.S. NIH Grant/Contract)

001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Feedback

Experimental group

Description:

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.

Treatment:

Device: Angulus

No Feedback

Other group

Description:

The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.

Treatment:

Device: Angulus