Effect of Angulus on Patient-elevation Compliance

Measuring the Effect of Angulus on Patient-elevation Compliance

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.

Study Overview

• Status: Completed
• Conditions: Hospital-acquired Pneumonia; Ventilator Associated Pneumonia; Hospital Acquired Condition; Ventilator Adverse Event; Recumbency; Head-of-bed
• Intervention / Treatment: Device: Angulus

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Angulus; Feedback on patient recumbency
Other: No Feedback; The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.	Device: Angulus; Feedback on patient recumbency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to Head of Bed Elevation to 30 Degree or More.	Measured as a continuous variable between 0% and 100% compliance.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency That Patients in the ICU Are Rotated More Than 30 Degree Within 24 Hour Days and Association With Development of Decubitus Ulcers.	As measured as categorical variable: incidence of decubitus ulcer	3 months
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.	As measured by continuous variable	3 months

Collaborators and Investigators

• Sponsor: Angulus, LLC
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Albert Einstein College of Medicine; Montefiore Medical Center
• Investigators: Principal Investigator: Michelle Gong, MD, Einstein College of Medicine, Division of Critical Care

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Iatrogenic Disease
• Other Study ID Numbers: 001 (NavyGHB); 1R43HL131177-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes