Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

NCT04078477 | Terminated

• 1 other identifier: RHL-NICU-2019-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of pressure ulcer

  Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)

  Through study completion, on average every 24 weeks.

Secondary Outcomes (2)

• Prolonging the stay in the NICU

  Through study completion, on average every 24 weeks.

• Cost effectiveness of patient´s NICU stay

  Through study completion, on average every 24 weeks.

Study Arms (2)

Lateral tilt bed

EXPERIMENTAL

Special lateral tilt bed.

Other: Body positioning

Body positioning

NO INTERVENTION

Standard NICU preventive strategy

Interventions

Body positioning OTHER

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

Lateral tilt bed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Intracranial hypertension
• Decubitus on the skin upon admission

Sponsors & Collaborators

• Regional Hospital Liberec: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

Regional Hospital Liberec

Liberec, 46010, Czechia

Location

MeSH Terms

Conditions

Pressure Ulcer; Unconsciousness

Interventions

Posture

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vendula Machackova, MSc., Ph.D.

  Department for Science and Reseach

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Research Randomizer
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurointensive Care Unit, Neurocenter

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

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: January 8, 2020
• Primary Completion: September 17, 2020
• Study Completion: October 9, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)