ClinicalTrials.gg
CompletedNCT03496220Updated Mar 6, 2024Results posted

Effect of Angulus on Patient-elevation Compliance

An interventional study of Angulus in Ventilator Adverse Event, Ventilator Associated Pneumonia and Hospital Acquired Condition, sponsored by Angulus, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Angulus, LLC · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 62 studies in Pneumonia, Ventilator-Associated with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Pneumonia, Ventilator-Associated · United States.

Enrollment
31st of 49
90 · median 149
Started
2018
with 1 other
No phase
20 of 62
2 open now
Registered
49th of 62
by date

Among the 62 studies in Pneumonia, Ventilator-Associated with a site in United States, this one is the 31st largest by enrollment of the 49 interventional ones that give a count, is one of 2 that started in 2018, is one of 20 with no phase, and was the 49th registered.

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

Browse Pneumonia, Ventilator-Associated studies →

Open to participants now

4 of the 62 studies in Pneumonia, Ventilator-Associated with a site in United States are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 48 Pneumonia, Ventilator-Associated studies recruiting now, 37 (77%) set no upper age limit and 6 (13%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Ventilator Adverse Event
  • Ventilator Associated Pneumonia
  • Hospital Acquired Condition
  • Hospital-acquired Pneumonia
  • Recumbency
  • Head-of-bed
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceAngulus

    Feedback on patient recumbency

06

What researchers measure

Primary outcomes

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

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

    Time frame: 3 months

07

Results

Posted Jan 19, 2021

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneICU A Feedback First, Then no Feedback, and Feedback LastICU B No Feedback First, Then Feedback, and No Feedback LastICU C: Feedback First, Then No Feedback, and Feedback Last
Started15410
Completed15410
Not completed000
Second Intervention
Participant flow — Second Intervention
MilestoneICU A Feedback First, Then no Feedback, and Feedback LastICU B No Feedback First, Then Feedback, and No Feedback LastICU C: Feedback First, Then No Feedback, and Feedback Last
Started17911
Completed17911
Not completed000
Third Intervention
Participant flow — Third Intervention
MilestoneICU A Feedback First, Then no Feedback, and Feedback LastICU B No Feedback First, Then Feedback, and No Feedback LastICU C: Feedback First, Then No Feedback, and Feedback Last
Started1185
Completed1185
Not completed000

Outcome measures

PrimaryCompliance to Head of Bed Elevation to 30 Degree or More.

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

Time frame:
3 months
Reported as:
Mean · percentage of time
Compliance to Head of Bed Elevation to 30 Degree or More.
percentage of timeFeedbackNo Feedback
Compliance to Head of Bed Elevation to 30 Degree or More.37.3 ± 26.232.4 ± 29.3

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Feedback0/49 (0%)0/49 (0%)0/49 (0%)
No Feedback0/41 (0%)0/41 (0%)0/41 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)FeedbackNo FeedbackTotal
<=18 years000
Between 18 and 65 years323163
>=65 years171027
Age, Continuous
Age, Continuous(years)FeedbackNo FeedbackTotal
Mean56.7 ± 12.758.7 ± 10.157.6 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)FeedbackNo FeedbackTotal
Female161935
Male332255
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)FeedbackNo FeedbackTotal
Hispanic or Latino181432
Not Hispanic or Latino312758
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)FeedbackNo FeedbackTotal
American Indian or Alaska Native011
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American171431
White121022
More than one race000
Unknown or Not Reported191635
Region of Enrollment
Region of Enrollment(participants)FeedbackNo FeedbackTotal
United States494190
08

Study locations

1 site
  • Montefiore Medical Center
    Bronx, New York 10461, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Sep 2018, 2 months.

Results were first posted in Jan 2021, 2 years 3 months after primary completion.

Of 82 interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 12, 2018
StartActual
Jul 10, 2018
Primary completionActual
Sep 30, 2018
CompletionActual
Sep 30, 2018
Results first posted
Jan 19, 2021
Last update
Mar 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03496220
Lead sponsor
Angulus, LLC
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
Jul 10, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Results posted
Jan 19, 2021
Last update
Mar 6, 2024

Study contacts

Michelle Gong, MD
principal investigator · Einstein College of Medicine, Division of Critical Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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