Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

NCT ID: NCT04078477

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2024-10-09

Brief Summary

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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

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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

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

SINGLE

Caregivers
Research Randomizer

Study Groups

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Lateral tilt bed

Special lateral tilt bed.

Group Type EXPERIMENTAL

Body positioning

Intervention Type OTHER

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

Body positioning

Standard NICU preventive strategy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Body positioning

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Regional Hospital Liberec

OTHER

Sponsor Role lead

Responsible Party

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Vera Spatenkova, MD, Ph.D.

Head of Neurointensive Care Unit, Neurocenter

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vendula Machackova, MSc., Ph.D.

Role: STUDY_CHAIR

Department for Science and Reseach

Locations

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Regional Hospital Liberec

Liberec, , Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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RHL-NICU-2019-01

Identifier Type: -

Identifier Source: org_study_id

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