Effect of Angulus on Patient-elevation Compliance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Clustered randomized cross over trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Feedback

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.

Group Type EXPERIMENTAL

Angulus

Intervention Type DEVICE

Feedback on patient recumbency

No Feedback

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

Group Type OTHER

Angulus

Intervention Type DEVICE

Feedback on patient recumbency

Interventions

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Angulus

Feedback on patient recumbency

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No