Head-of-bed, Hospital Acquired Condition, Hospital-acquired Pneumonia, Recumbency, Ventilator Adverse Event, Ventilator Associated Pneumonia
Conditions
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
Feedback on patient recumbency
Sponsors
Study design
Intervention model description
Clustered randomized cross over trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Compliance to Head of Bed Elevation to 30 Degree or More. | 3 months | Measured as a continuous variable between 0% and 100% compliance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 90 |
Baseline characteristics
| Characteristic | Feedback | No Feedback | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 10 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 31 Participants | 63 Participants |
| Age, Continuous | 56.7 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 Participants | 14 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 27 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 14 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 16 Participants | 35 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 22 Participants |
| Region of Enrollment United States | 49 participants | 41 participants | 90 participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 33 Participants | 22 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 41 |
| other Total, other adverse events | 0 / 49 | 0 / 41 |
| serious Total, serious adverse events | 0 / 49 | 0 / 41 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback | Compliance to Head of Bed Elevation to 30 Degree or More. | 37.3 percentage of time | Standard Deviation 26.2 |
| No Feedback | Compliance to Head of Bed Elevation to 30 Degree or More. | 32.4 percentage of time | Standard Deviation 29.3 |