Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care (PULAT-NC)

December 4, 2023 updated by: Vera Spatenkova, MD, Ph.D., Regional Hospital Liberec

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateral tilt bed
Special lateral tilt bed.
Other: Body positioning
Comparison lateral tilt bed to standard patient´s body positioning in the bed.
No Intervention: Body positioning
Standard NICU preventive strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, on average every 24 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Liberec

Collaborators

Charles University, Czech Republic

Investigators

  • Study Chair: Vendula Machackova, MSc., Ph.D., Department for Science and Reseach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 28, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHL-NICU-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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