Ventilator Adverse EventNCT03496220
Effect of Angulus on Patient-elevation Compliance
A study testing Angulus in people with Ventilator Adverse Event and Ventilator Associated Pneumonia, run by Angulus, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition
- What is being tested?
- Angulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
- Age between 18 and 75 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Measuring the Effect of Angulus on Patient-elevation Compliance
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.
- Conditions
- Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia, Recumbency, Head-of-bed
- Being tested
- Angulus
- Medical subject headings
- Pneumonia, Ventilator-Associated, Iatrogenic Disease, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngulusDevice
Feedback on patient recumbency
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Angulus |
| 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. Receives: Device: Angulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to Head of Bed Elevation to 30 Degree or More.
Measured as a continuous variable between 0% and 100% compliance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start10 Jul 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventilator Adverse EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clustered randomized cross over trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angulus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albert Einstein College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Michelle Gong, MD, Principal investigator, Einstein College of Medicine, Division of Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496220
- Sponsor's protocol ID
- 001
- Other IDs
- 1R43HL131177-01A1
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2018
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of Angulus on Patient-elevation Compliance
- ClinicalTrials.gov ID
- NCT03496220
- Acronym / sponsor ID
- 001
- Conditions
- Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia, Recumbency, Head-of-bed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Angulus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Albert Einstein College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Montefiore Medical Center
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clustered randomized cross over trial
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Device: AngulusThe 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. |
| No Feedback | Other | Device: AngulusThe Angulus device will be on the patient but will NOT have the corresponding display data on patient elevation available to nurses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilation with any modality (e.g., endotracheal tube, tracheostomy)
- Age between 18 and 75 years
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngulusFeedback on patient recumbency | Device | Feedback, No Feedback |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Not yet recruiting
Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Gong, MD principal investigator
Einstein College of Medicine, Division of Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angulus in people with Ventilator Adverse Event and Ventilator Associated Pneumonia, run by Angulus, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to Head of Bed Elevation to 30 Degree or More. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.