Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04078477

Acronym

PULAT-NC

Enrollment

300

Registered

2019-09-06

Start date

2020-01-08

Completion date

2024-10-09

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy

Brief 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.

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.

Interventions

OTHERBody positioning

Comparison lateral tilt bed to standard patient´s body positioning in the bed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Masking description

Research Randomizer

Intervention model description

Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary brain disease * Hospitalization in JIP neurocenter * Age\> 18 years * Unconsciousness * Artificial pulmonary ventilation

Exclusion criteria

* Intracranial hypertension * Decubitus on the skin upon admission

Design outcomes

Primary

Measure	Time frame	Description
Incidence of pressure ulcer	Through study completion, on average every 24 weeks.	Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)

Secondary

Measure	Time frame	Description
Prolonging the stay in the NICU	Through study completion, on average every 24 weeks.	The incidence of the pressure ulcer shall prolong the patient´s NICU stay
Cost effectiveness of patient´s NICU stay	Through study completion, on average every 24 weeks.	Therapeutic Intervention Scoring System (TISS)

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026