Clinical trial NCT03496220: Effect of Angulus on Patient-elevation Compliance
Official title: Measuring the Effect of Angulus on Patient-elevation Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Adverse Event
Ventilator Associated Pneumonia
Hospital Acquired Condition
Hospital-acquired Pneumonia
Recumbency
Head-of-bed
Lead sponsor: Angulus, LLC
Sponsor class: INDUSTRY
Collaborators: name: Albert Einstein College of Medicine
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Montefiore Medical Center
First posted: 2018-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Clustered randomized cross over trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance to Head of Bed Elevation to 30 Degree or More.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Einstein College of Medicine, Division of Critical Care
name: Michelle Gong, MD
role: PRINCIPAL_INVESTIGATOR
References: