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NCT04078477 Clinical Trial

Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Pressure Ulcer Clinical Trial

— PULAT-NC  

Official title:
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04078477
Other study ID # RHL-NICU-2019-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2020
Est. completion date December 30, 2024

Study information
Verified date December 2023
Source Regional Hospital Liberec
Contact Vera Spatenkova, MD, Ph.D.
Phone 00420 724 027 126
Email vera.spatenkova@nemlib.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Body positioning
Comparison lateral tilt bed to standard patient´s body positioning in the bed.

Locations
Country Name City State
Czechia Regional Hospital Liberec Liberec

Sponsors (2)
Lead Sponsor Collaborator
Regional Hospital Liberec Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Prolonging the stay in the NICU The incidence of the pressure ulcer shall prolong the patient´s NICU stay Through study completion, on average every 24 weeks.
Secondary Cost effectiveness of patient´s NICU stay Therapeutic Intervention Scoring System (TISS) Through study completion, on average every 24 weeks.
See also
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Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A