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

Fundación Cardioinfantil Instituto de Cardiología3,300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

3,300

Conditions

Critical Illness

Interventions

High frequency postural changeOTHER

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.

Conventional careOTHER

Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The ICU manage adult patients, over 18 years of age, with any type of emphasis (surgical, medical, neurological, or mixed); * Patients are admitted in critical condition (with life support); * The director accepts the commitment of the care assigned in the randomization (for a period of 3 months). Exclusion Criteria: * Intermediate care units in which patients mobilize themselves. * Covid patients or other patients exposed to different mobilization patterns (e.g., 12 hours prone vs 12 supine)

Locations (21)

Hospital IPS Universitaria

Medellín, Antioquia, Colombia

Hospital San Vicente de Paul

Medellín, Antioquia, Colombia

Outcomes

Primary Outcomes

The incidence (incidence rata ration) of new pressure ulcers in each Intensive Care Unit (ICU)

The number of pressure injuries at any stage, new acquired in the ICU after admission per 1,000 patient days in the ICU.

Time frame: " 1 month after admission"

Secondary Outcomes

Risk index (HR) and time to event of Pressure ulcers of the patients

Hazard ratio and tiem to event of PUs of patients included in the repositioning group with the lowest frequency compared to the group of patients included by intervention group in the development of the first PU during their stay in the ICU.

Time frame: "1 month safter admission"

Security outcomes

Secondary safety outcomes: includes possible complications associated with postural changes: permanent or sporadic changes in ventilatory parameters (hypoxemia), hemodynamic changes (tachycardia, hypertension); events such as acute respiratory failure; or cardiogenic shock, pneumonia.

Time frame: "1 month after admission"

Data from ClinicalTrials.gov

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