Pressure UlcerPULAT-NCNCT04078477
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
A study testing Body positioning in people with Pressure Ulcer, run by Regional Hospital Liberec at 1 site in Czechia.
Trial summary
Patient positioning is an essential part of a preventive strategy for neurocritical care patients. The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer. 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?
- Body positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Jan 2020to 9 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary brain disease
- Hospitalization in JIP neurocenter
- Age> 18 years
- Unconsciousness
- Artificial pulmonary ventilation
Who cannot join
- Intracranial hypertension
- Decubitus on the skin upon admission
Trial locations and contacts
1 site in 1 country.
About this study
Patient positioning is an essential part of a preventive strategy for neurocritical care patients.
The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.
Read the detailed description
In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.
- Conditions
- Pressure Ulcer
- Being tested
- Body positioning
- Keywords
- Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy
- Medical subject headings
- Pressure Ulcer, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body positioningOther
Comparison lateral tilt bed to standard patient´s body positioning in the bed.
| Study group | Role | What they receive |
|---|---|---|
| Lateral tilt bed | Experimental | Special lateral tilt bed. Receives: Other: Body positioning |
| Body positioning | No intervention | Standard NICU preventive strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pressure ulcer
Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)
Measured: Through study completion, on average every 24 weeks.
Secondary outcomes (2)
Prolonging the stay in the NICU
The incidence of the pressure ulcer shall prolong the patient´s NICU stay
Measured: Through study completion, on average every 24 weeks.
Cost effectiveness of patient´s NICU stay
Therapeutic Intervention Scoring System (TISS)
Measured: Through study completion, on average every 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start8 Jan 2020
- Primary completion17 Sep 2020
- Study completion9 Oct 2024
Why it stopped: In accordance with the interim statistical analysis conducted after 250 patients.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Liberec
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Vera Spatenkova, MD, Ph.D., Regional Hospital Liberec
- Investigators
- Vendula Machackova, MSc., Ph.D., Study chair, Department for Science and Reseach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078477
- Sponsor's protocol ID
- RHL-NICU-2019-01
- Acronym
- PULAT-NC
- Status last verified
- Apr 2025
- First submitted
- 28 Aug 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
- ClinicalTrials.gov ID
- NCT04078477
- Acronym / sponsor ID
- PULAT-NC / RHL-NICU-2019-01
- Conditions
- Pressure Ulcer
- Keywords
- Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In accordance with the interim statistical analysis conducted after 250 patients.
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Regional Hospital LiberecUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
Patient positioning is an essential part of a preventive strategy for neurocritical care patients.
The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.
Detailed description
In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
| Arm | Type | Receives |
|---|---|---|
| Lateral tilt bed | Experimental | Other: Body positioningSpecial lateral tilt bed. |
| Body positioning | No intervention | –Standard NICU preventive strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary brain disease
- Hospitalization in JIP neurocenter
- Age> 18 years
- Unconsciousness
- Artificial pulmonary ventilation
Key exclusion criteria (2 listed)
- Intracranial hypertension
- Decubitus on the skin upon admission
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 |
|---|---|---|
| Body positioningComparison lateral tilt bed to standard patient´s body positioning in the bed. | Other | Lateral tilt bed |
Primary outcome
Incidence of pressure ulcer
Time frame: Through study completion, on average every 24 weeks.
Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)
2 secondary outcomes
Prolonging the stay in the NICU
Time frame: Through study completion, on average every 24 weeks.
Cost effectiveness of patient´s NICU stay
Time frame: Through study completion, on average every 24 weeks.
Results and safety
The study was stopped early (reason given: In accordance with the interim statistical analysis conducted after 250 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No. The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Vendula Machackova, MSc., Ph.D. study chair
Department for Science and Reseach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body positioning in people with Pressure Ulcer, run by Regional Hospital Liberec at 1 site in Czechia.
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 5 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: stopped early, as of the sponsor's last update on 6 Apr 2025. 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 Czechia. 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?
The study was stopped early (reason given: In accordance with the interim statistical analysis conducted after 250 patients.). 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 ulcer (time frame: Through study completion, on average every 24 weeks.). 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 Apr 2025.