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Effect of Angulus on Patient-elevation Compliance

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ClinicalTrials.gov Identifier: NCT03496220
Recruitment Status : Completed
First Posted : April 12, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Montefiore Medical Center
Information provided by (Responsible Party):
Angulus, LLC

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Clustered randomized cross over trial
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Angulus, LLC
Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Montefiore Medical Center
Investigators
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Principal Investigator: Michelle Gong, MD Einstein College of Medicine, Division of Critical Care
  Study Documents (Full-Text)

Documents provided by Angulus, LLC:
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Responsible Party: Angulus, LLC
ClinicalTrials.gov Identifier: NCT03496220    
Other Study ID Numbers: 001
1R43HL131177-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Pneumonia
Iatrogenic Disease
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Disease Attributes
Pathologic Processes