Pressure UlcerLS-HAPUNCT02533726
Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers
A study testing Optimal Turning and Patient Sensor in people with Pressure Ulcer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Optimal Turning and Patient Sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,312 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years of age)
- Admission to Intensive Care Unit
Who cannot join
- Children (<18 years of age)
- Adhesive allergy
- Physical limitation for sensor application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.
Read the detailed description
This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.
Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.
- Conditions
- Pressure Ulcer
- Being tested
- Optimal Turning, Standard Care Practices, Patient Sensor
- Keywords
- Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal TurningOther
Also called Patient Turning, Pressure Ulcer Prevention
Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.
Standard Care PracticesOther
Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.
Patient SensorOther
Also called Leaf Healthcare Patient Monitoring Sensor
A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Optimal Turning | Experimental | All patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.). Receives: Other: Optimal Turning; Other: Patient Sensor |
| Control - Standard Care | Active comparator | All patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary. Receives: Other: Standard Care Practices; Other: Patient Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.
- Stage 1: Non-blanchable erythema of intact skin
- Stage 2: Partial-thickness skin loss with exposed dermis
- Stage 3: Full-thickness skin loss
- Stage 4: Full-thickness skin and tissue loss
- Unstageable: Obscured full-thickness skin and tissue loss
- Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration
Measured: Duration of ICU admission (average 1 week)
Secondary outcomes (1)
Compliance With Patient Turning Procedures
Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.
Measured: Duration of ICU admission (average 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Leaf Healthcare, Inc.
- Responsible party
- Principal investigator, David Pickham, Stanford University
- Investigators
- David Pickham, PhD, Principal investigator, Stanford Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533726
- Sponsor's protocol ID
- 33144
- Acronym
- LS-HAPU
- Status last verified
- Sep 2017
- First submitted
- 17 Aug 2015
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pickham D, Ballew B, Ebong K, Shinn J, Lough ME, Mayer B. Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:190. doi: 10.1186/s13063-016-1313-5.
PubMed 27053145
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
- ClinicalTrials.gov ID
- NCT02533726
- Acronym / sponsor ID
- LS-HAPU / 33144
- Conditions
- Pressure Ulcer
- Keywords
- Bed Sores, Bedsores, Decubitus Ulcer, Pressure Sore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,312 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Leaf Healthcare, Inc.
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.
Detailed description
This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.
Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment - Optimal Turning | Experimental | Other: Optimal Turning, Other: Patient SensorAll patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.). |
| Control - Standard Care | Active comparator | Other: Standard Care Practices, Other: Patient SensorAll patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (>18 years of age)
- Admission to Intensive Care Unit
Key exclusion criteria (3 listed)
- Children (<18 years of age)
- Adhesive allergy
- Physical limitation for sensor application
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 |
|---|---|---|
| Optimal TurningAlso: Patient Turning, Pressure Ulcer PreventionPatients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn. | Other | Treatment - Optimal Turning |
| Standard Care PracticesPatients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor. | Other | Control - Standard Care |
| Patient SensorAlso: Leaf Healthcare Patient Monitoring SensorA small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside. | Other | Control - Standard Care, Treatment - Optimal Turning |
Primary outcome
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
Time frame: Duration of ICU admission (average 1 week)
NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported. * Stage 1: Non-blanchable erythema of intact skin * Stage 2: Partial-thickness skin loss with exposed dermis * Stage 3: Full-thickness skin loss * Stage 4: Full-thickness skin and tissue loss * Unstageable: Obscured full-thickness skin and tissue loss * Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration
1 secondary outcome
Compliance With Patient Turning Procedures
Time frame: Duration of ICU admission (average 1 week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27053145Pickham D, Ballew B, Ebong K, Shinn J, Lough ME, Mayer B. Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:190. doi: 10.1186/s13063-016-1313-5.
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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.
David Pickham, PhD principal investigator
Stanford Health 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 Optimal Turning and Patient Sensor in people with Pressure Ulcer, run by Stanford University 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 3 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 9 Apr 2018. 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 9 Apr 2018). 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?
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers (time frame: Duration of ICU admission (average 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02533726, which also lists 1 linked publication.
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 9 Apr 2018.