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Effect of Angulus on Patient-elevation Compliance

Measuring the Effect of Angulus on Patient-elevation Compliance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496220
Enrollment
90
Registered
2018-04-12
Start date
2018-07-10
Completion date
2018-09-30
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEAngulus

Feedback on patient recumbency

Sponsors

Albert Einstein College of Medicine
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Montefiore Medical Center
CollaboratorOTHER
Angulus, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Clustered randomized cross over trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance to Head of Bed Elevation to 30 Degree or More.3 monthsMeasured as a continuous variable between 0% and 100% compliance.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Angulus: Feedback on patient recumbency
49
No Feedback
The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. Angulus: Feedback on patient recumbency
41
Total90

Baseline characteristics

CharacteristicFeedbackNo FeedbackTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
17 Participants10 Participants27 Participants
Age, Categorical
Between 18 and 65 years
32 Participants31 Participants63 Participants
Age, Continuous56.7 years
STANDARD_DEVIATION 12.7
58.7 years
STANDARD_DEVIATION 10.1
57.6 years
STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB)
Hispanic or Latino
18 Participants14 Participants32 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants27 Participants58 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
17 Participants14 Participants31 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants16 Participants35 Participants
Race (NIH/OMB)
White
12 Participants10 Participants22 Participants
Region of Enrollment
United States
49 participants41 participants90 participants
Sex: Female, Male
Female
16 Participants19 Participants35 Participants
Sex: Female, Male
Male
33 Participants22 Participants55 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 41
other
Total, other adverse events
0 / 490 / 41
serious
Total, serious adverse events
0 / 490 / 41

Outcome results

Primary

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

Population: Time spent in evidence based recumbency range comparison.

ArmMeasureValue (MEAN)Dispersion
FeedbackCompliance to Head of Bed Elevation to 30 Degree or More.37.3 percentage of timeStandard Deviation 26.2
No FeedbackCompliance to Head of Bed Elevation to 30 Degree or More.32.4 percentage of timeStandard Deviation 29.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026