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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

Tracking Information
First Submitted Date  ICMJE April 2, 2018
First Posted Date  ICMJE April 12, 2018
Results First Submitted Date  ICMJE August 4, 2020
Results First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE July 10, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Compliance to Head of Bed Elevation to 30 Degree or More. [ Time Frame: 6 months ]
Measured as a continuous variable between 0% and 100% compliance.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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: 6 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: 6 months ]
    As measured by continuous variable
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Angulus on Patient-elevation Compliance
Official Title  ICMJE Measuring the Effect of Angulus on Patient-elevation Compliance
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Clustered randomized cross over trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Ventilator Adverse Event
  • Ventilator Associated Pneumonia
  • Hospital Acquired Condition
  • Hospital-acquired Pneumonia
  • Recumbency
  • Head-of-bed
Intervention  ICMJE Device: Angulus
Feedback on patient recumbency
Study Arms  ICMJE
  • 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.
    Intervention: Device: Angulus
  • No Feedback
    The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses.
    Intervention: Device: Angulus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
200
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03496220
Other Study ID Numbers  ICMJE 001
1R43HL131177-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Angulus, LLC
Study Sponsor  ICMJE Angulus, LLC
Collaborators  ICMJE
  • Albert Einstein College of Medicine
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Michelle Gong, MD Einstein College of Medicine, Division of Critical Care
PRS Account Angulus, LLC
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP