Effect of Angulus on Patient-elevation Compliance

Ventilator Associated Pneumonia Clinical Trial

Official title:

Measuring the Effect of Angulus on Patient-elevation Compliance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496220
• Other study ID #: 001
• Secondary ID: 1R43HL131177-01A
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2024
• Source: Angulus, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head-of-bed
• Healthcare-Associated Pneumonia
• Hospital Acquired Condition
• Hospital-acquired Pneumonia
• Iatrogenic Disease
• Pneumonia
• Pneumonia, Ventilator-Associated
• Recumbency
• Ventilator Adverse Event
• Ventilator Associated Pneumonia

Intervention

Device:
• Angulus
Feedback on patient recumbency

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Angulus, LLC	Albert Einstein College of Medicine, Montefiore Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance to Head of Bed Elevation to 30 Degree or More.	Measured as a continuous variable between 0% and 100% compliance.	3 months