NCT04604665

Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers

Evaluation of the Efficacy of Two Levels of Frequency of Repositioning in Adults Hospitalized in Intensive Care Units, in the Reduction of Pressure Ulcers: A Randomized Cluster Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,300 (actual)
• Sponsor: Fundación Cardioinfantil Instituto de Cardiología · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

PENFUP FASE 2, It is a multicenter study by parallel conglomerates, planned in order to evaluate the efficacy between two levels of frequency of postural change in intensive care units for adults of hospitals in various regions of Colombia.

Detailed 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 obtaining a total of 1,650 patients in each arm of the study and a total of 3,300 participants in the study.

Conditions

• Critical Illness

Interventions

Type	Name	Description
OTHER	High frequency postural change	Repositioning of patients hospitalized in bed in intensive care units will be carried out with a frequency interval that we call "high-frequency" to be performed on each patient between an interval between less than or equal to every 2 hours in a full day (24 hours) (minimum goal of 8-10 in 24 hours subtracting 2 or 4 at night and not alter the circadian cycle). The position must be modified in each postural change to right lateral, supine, left lateral, or prone to supine if the position changes every 2 hrs.
OTHER	Conventional care	Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.

Timeline

• Start date: 2021-04-10
• Primary completion: 2023-12-10
• Completion: 2023-12-10
• First posted: 2020-10-27
• Last updated: 2024-01-22

Locations

21 sites across 1 country: Colombia