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

Sponsor

Regional Hospital Liberec (Other)

Overall Status

Recruiting

CT.gov ID

NCT04078477

Collaborator

Charles University, Czech Republic (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Other: Body positioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Care Provider)

Masking Description:

Research Randomizer

Primary Purpose:

Prevention

Official Title:

Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Actual Study Start Date :

Jan 8, 2020

Anticipated Primary Completion Date :

Jan 8, 2023

Anticipated Study Completion Date :

Jan 8, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of pressure ulcer [Through study completion, on average every 24 weeks.]
Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel)

Secondary Outcome Measures

Prolonging the stay in the NICU [Through study completion, on average every 24 weeks.]
The incidence of the pressure ulcer shall prolong the patient´s NICU stay
Cost effectiveness of patient´s NICU stay [Through study completion, on average every 24 weeks.]
Therapeutic Intervention Scoring System (TISS)