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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HL131177-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Albert Einstein College of Medicine | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Montefiore Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feedback | Experimental | 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. |
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| No Feedback | Other | The Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angulus | Device | Feedback on patient recumbency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to Head of Bed Elevation to 30 Degree or More. | Measured as a continuous variable between 0% and 100% compliance. | 3 months |
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Inclusion 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:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Gong, MD | Einstein College of Medicine, Division of Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ICU A Feedback First, Then no Feedback, and Feedback Last | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period 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 |
| FG001 | ICU B No Feedback First, Then Feedback, and No Feedback Last | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period 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 |
| FG002 | ICU C: Feedback First, Then No Feedback, and Feedback Last | During the feedback period ICU will be equipped with display device corresponding to each Angulus device with an interactive software interface which displays the patient's elevation. In the No Feedback period 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | No Feedback |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance to Head of Bed Elevation to 30 Degree or More. | Measured as a continuous variable between 0% and 100% compliance. | Time spent in evidence based recumbency range comparison. | Posted | Mean | Standard Deviation | percentage of time | 3 months |
|
3 months
No adverse events were noted as a result of participation in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Perry Dubin | Angulus | (917) 426-5911 | perry@angulus.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2016 | Sep 9, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D007049 | Iatrogenic Disease |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Clustered randomized cross over trial
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| NOT COMPLETED |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |