Pressure UlcerNCT03048357
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
A study testing Freedom Bed and Standard hospital bed in people with Pressure Ulcer, run by Northeast Center for Rehabilitation and Brain Injury.
Trial summary
Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Freedom Bed and Standard hospital bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects or their legal representative able to provide written consent for study Must be rated between 6-12 on the Baden Scale Must be immobile and unable to preposition themselves. Must be within weight range of designated support surface.
Who cannot join
- Subjects with unstable spinal fractures. Subjects with significant involuntary spasms. Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.
- Subjects considered morbidly obese.
About this study
Official title: Effectiveness of the Freedom Bed, Automatic Continuous Lateral Rotation Therapy System as Compared to a Standard Hospital Mattress With Manual Caregiver Turning Every 2 Hours for Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.
Read the detailed description
This study will include 8 vent dependent subjects with comparable diagnoses and nutritional levels. Of the subjects selected, 4 subjects will be placed on Freedom Beds and 4 will be placed on standard hospital beds for a period not less than 6 months. A waiver of informed consent is required prior to bed placement and data collection. Consented subjects will have primary and secondary diagnosis recorded, pressure mapping in supine 30-degree elevation, assessment of ventilator / oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily skin assessments and treatment as prescribed by the attending physician with weekly measurements and reporting of values. Subjects will continue until they reach one of the study endpoints: 1) discharge from the vent unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.
Subjects placed on the Freedom Bed will be automatically turned in accordance with positions determined as optimal by initial pressure mapping and approved by the attending physician. All programmable turning angles, dwell times, head and leg elevations must be "dialed in" within a week of the study beginning. Any modification to the program during the study must be approved by the care team and documented accordingly.
Subjects placed on standard hospital bed will require manual re-positioning every 2 hours. All turning and/or re-positioning must be timed and documented.
Subjects who experience either development of pressure injuries, or worsening of their skin condition to the point a specialty bed is required will be deemed a test failure.
The primary and secondary outcome measures documented on each subject throughout the week will be collected by the Clinical Research Coordinator (CRC) on a weekly basis and submitted to the Principal Investigator. The weekly reports will then be consolidated by the CRC into a monthly report and submitted to the Institutional Review Board (IRB), Principal Investigators (PI) and Supervising Authorities (SA) for review.
- Conditions
- Pressure Ulcer
- Being tested
- Freedom Bed, Standard hospital bed
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom BedDevice
Fully Integrated Lateral Rotation Bed System that automatically turns the patient to a specific angle in degrees between from 15-25 with dwell times between 1-120 minutes.
Standard hospital bedOther
Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.
| Study group | Role | What they receive |
|---|---|---|
| Freedom Bed | Active comparator | Freedom Bed Continuous Lateral Rotation Therapy System Receives: Device: Freedom Bed |
| Standard Hospital Bed & Protocol | Other | Standard Hospital Bed with manual caregiver re-positioning every 2 hours Receives: Other: Standard hospital bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pressure Injury
Measured: 12 months
Secondary outcomes (1)
Incidence of Pneumonia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Sep 2016
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeast Center for Rehabilitation and Brain Injury
- Sponsor type
- University, hospital or other
- Collaborators
- Probed Medical USA
- Responsible party
- Principal investigator, Annmarie Belfiglio, Northeast Center for Rehabilitation and Brain Injury
- Investigators
- Lorraine McCalister, M.S., Study director, Director Of Therapy, Northeast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048357
- Sponsor's protocol ID
- Protocol 2
- Status last verified
- Apr 2017
- First submitted
- 7 Feb 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Freedom Bed, Automatic Continuous Lateral Rotation Therapy System as Compared to a Standard Hospital Mattress With Manual Caregiver Turning Every 2 Hours for Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT03048357
- Acronym / sponsor ID
- Protocol 2
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Northeast Center for Rehabilitation and Brain InjuryUniversity, hospital or other
- Collaborators
- Probed Medical USA
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Nov 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.
Detailed description
This study will include 8 vent dependent subjects with comparable diagnoses and nutritional levels. Of the subjects selected, 4 subjects will be placed on Freedom Beds and 4 will be placed on standard hospital beds for a period not less than 6 months. A waiver of informed consent is required prior to bed placement and data collection. Consented subjects will have primary and secondary diagnosis recorded, pressure mapping in supine 30-degree elevation, assessment of ventilator / oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily skin assessments and treatment as prescribed by the attending physician with weekly measurements and reporting of values. Subjects will continue until they reach one of the study endpoints: 1) discharge from the vent unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.
Subjects placed on the Freedom Bed will be automatically turned in accordance with positions determined as optimal by initial pressure mapping and approved by the attending physician. All programmable turning angles, dwell times, head and leg elevations must be "dialed in" within a week of the study beginning. Any modification to the program during the study must be approved by the care team and documented accordingly.
Subjects placed on standard hospital bed will require manual re-positioning every 2 hours. All turning and/or re-positioning must be timed and documented.
Subjects who experience either development of pressure injuries, or worsening of their skin condition to the point a specialty bed is required will be deemed a test failure.
The primary and secondary outcome measures documented on each subject throughout the week will be collected by the Clinical Research Coordinator (CRC) on a weekly basis and submitted to the Principal Investigator. The weekly reports will then be consolidated by the CRC into a monthly report and submitted to the Institutional Review Board (IRB), Principal Investigators (PI) and Supervising Authorities (SA) for review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freedom Bed | Active comparator | Device: Freedom BedFreedom Bed Continuous Lateral Rotation Therapy System |
| Standard Hospital Bed & Protocol | Other | Other: Standard hospital bedStandard Hospital Bed with manual caregiver re-positioning every 2 hours |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects or their legal representative able to provide written consent for study Must be rated between 6-12 on the Baden Scale Must be immobile and unable to preposition themselves. Must be within weight range of designated support surface.
Key exclusion criteria (2 listed)
- Subjects with unstable spinal fractures. Subjects with significant involuntary spasms. Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.
- Subjects considered morbidly obese.
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 |
|---|---|---|
| Freedom BedFully Integrated Lateral Rotation Bed System that automatically turns the patient to a specific angle in degrees between from 15-25 with dwell times between 1-120 minutes. | Device | Freedom Bed |
| Standard hospital bedCaregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's. | Other | Standard Hospital Bed & Protocol |
Primary outcome
Incidence of Pressure Injury
Time frame: 12 months
1 secondary outcome
Incidence of Pneumonia
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Lorraine McCalister, M.S. study director
Director Of Therapy, Northeast Center
Questions about this trial
What is this clinical trial studying?
A study testing Freedom Bed and Standard hospital bed in people with Pressure Ulcer, run by Northeast Center for Rehabilitation and Brain Injury.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Incidence of Pressure Injury (time frame: 12 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 17 Apr 2017.