Effect of Angulus on Patient-elevation Compliance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03496220|
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Adverse Event Ventilator Associated Pneumonia Hospital Acquired Condition Hospital-acquired Pneumonia Recumbency Head-of-bed||Device: Angulus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Clustered randomized cross over trial|
|Masking:||None (Open Label)|
|Official Title:||Measuring the Effect of Angulus on Patient-elevation Compliance|
|Actual Study Start Date :||July 10, 2018|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
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.
Feedback on patient recumbency
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
Feedback on patient recumbency
- Compliance to Head of Bed Elevation to 30 Degree or More. [ Time Frame: 3 months ]Measured as a continuous variable between 0% and 100% compliance.
- Frequency That Patients in the ICU Are Rotated More Than 30 Degree Within 24 Hour Days and Association With Development of Decubitus Ulcers. [ Time Frame: 3 months ]As measured as categorical variable: incidence of decubitus ulcer
- Frequency That Patients in the ICU Rotate More Than 30 Degree and Have Change in Elevation of More Than 15 Degree Within an Hour and Correlation With Agitation as Indicated by RASS. [ Time Frame: 3 months ]As measured by continuous variable
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496220
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Michelle Gong, MD||Einstein College of Medicine, Division of Critical Care|