Ventilator Associated Pneumonia Clinical Trial
Official title:
Measuring the Effect of Angulus on Patient-elevation Compliance
Verified date | February 2024 |
Source | Angulus, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Angulus, LLC | Albert Einstein College of Medicine, Montefiore Medical Center, National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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