Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Critical Illness
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Clinical trial, randomized, pragmatic, of parallel groups (1: 1), by clusters, blinded for the collection of information, sending, and in the evaluation of outcomes.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Telephone randomization Random numbers centers Blinded for analyst and researchersPrimary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
Taking into account a design effect of 6.7, Investigators planned to include 150 participants from each ICU. Investigators did calculate that a total of 22 ICUs are required, in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until ...
Taking into account a design effect of 6.7, Investigators planned to include 150 participants from each ICU. Investigators did calculate that a total of 22 ICUs are required, in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until obtaining a total of 1,650 patients in each arm of the study and a total of 3,300 participants in the study.
Tracking Information
- NCT #
- NCT04604665
- Collaborators
- Universidad Autónoma de Bucaramanga
- Investigators
- Principal Investigator: Olga L Cortés, PhD Fundación Cardioinfantil Instituto de Cardiología