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Effect of Angulus on Patient-elevation Compliance

A

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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