search
Back to results

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

Primary Purpose

Pressure Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Body positioning
Sponsored by
Regional Hospital Liberec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Regional Hospital LiberecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lateral tilt bed

Body positioning

Arm Description

Special lateral tilt bed.

Standard NICU preventive strategy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prolonging the stay in the NICU
The incidence of the pressure ulcer shall prolong the patient´s NICU stay
Cost effectiveness of patient´s NICU stay
Therapeutic Intervention Scoring System (TISS)

Full Information

First Posted
August 28, 2019
Last Updated
January 2, 2023
Sponsor
Regional Hospital Liberec
Collaborators
Charles University, Czech Republic
search

1. Study Identification

Unique Protocol Identification Number
NCT04078477
Brief Title
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
Acronym
PULAT-NC
Official Title
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Liberec
Collaborators
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
Masking
Care Provider
Masking Description
Research Randomizer
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lateral tilt bed
Arm Type
Experimental
Arm Description
Special lateral tilt bed.
Arm Title
Body positioning
Arm Type
No Intervention
Arm Description
Standard NICU preventive strategy
Intervention Type
Other
Intervention Name(s)
Body positioning
Intervention Description
Comparison lateral tilt bed to standard patient´s body positioning in the bed.
Primary Outcome Measure Information:
Title
Incidence of pressure ulcer
Description
Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)
Time Frame
Through study completion, on average every 24 weeks.
Secondary Outcome Measure Information:
Title
Prolonging the stay in the NICU
Description
The incidence of the pressure ulcer shall prolong the patient´s NICU stay
Time Frame
Through study completion, on average every 24 weeks.
Title
Cost effectiveness of patient´s NICU stay
Description
Therapeutic Intervention Scoring System (TISS)
Time Frame
Through study completion, on average every 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Spatenkova, MD, Ph.D.
Phone
00420 724 027 126
Email
vera.spatenkova@nemlib.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Vendula Machackova, MSc., Ph.D.
Phone
00420 724 600 739
Email
vendula.machackova@nemlib.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vendula Machackova, MSc., Ph.D.
Organizational Affiliation
Department for Science and Reseach
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
46010
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Spatenkova, MD, Ph.D.
Phone
00420 724 027 126
Email
vera.spatenkova@nemlib.cz
First Name & Middle Initial & Last Name & Degree
Vendula Machackova, MSc., Ph.D.
Phone
00420 724 600 739
Email
vendula.machackova@nemlib.cz

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

Learn more about this trial

Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

We'll reach out to this number within 24 hrs