Effect of Angulus on Patient-elevation Compliance

NCT03496220 | Completed Results DMC FDA Device

• 2 other identifiers: 0011R43HL131177-01A1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Adverse Event; Ventilator Associated Pneumonia; Hospital Acquired Condition; Hospital-acquired Pneumonia; Recumbency; Head-of-bed

Outcome Measures

Primary Outcomes (1)

• Compliance to Head of Bed Elevation to 30 Degree or More.

  Measured as a continuous variable between 0% and 100% compliance.

  3 months

Study Arms (2)

Feedback

EXPERIMENTAL

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

No Feedback

OTHER

The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.

Device: Angulus

Interventions

Angulus DEVICE

Feedback on patient recumbency

Feedback; No Feedback

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
• Age between 18 and 75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Angulus, LLC: lead
• Albert Einstein College of Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Iatrogenic Disease; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Perry Dubin
• Organization: Angulus

perry@angulus.us

‪(917) 426-5911‬

Study Officials

• Michelle Gong, MD

  Einstein College of Medicine, Division of Critical Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clustered randomized cross over trial

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 12, 2018
• Study Start: July 10, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: March 6, 2024
• Results First Posted: January 19, 2021

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)