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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Critical Illness

Intervention / Treatment
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* Other: High frequency postural change
* Other: Conventional care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High frequency postural change<br>Repositioning or rotation of patients hospitalized in bed in intensive care units will be carried out with a frequency interval that we call high-frequency. It has to be performed on each patient between an interval 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 the right lateral, supine, left lateral, supine, or prone position to supine position. The repositioning will be provided until a patient is discharged from ICU, die or begin ambulation. When providing each repositioning, avoid dragging the patient, the shear, and the friction to increase UPP risk. This must be applied to avoiding massage. Patients in any position should use pressure-reducing items such as pillows. | Other: High frequency postural change<br>* 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.<br>* Other names: Repositioning;|
| Active Comparator: Conventional care<br>Repositioning or rotation of patients hospitalized will be the conventional or usual care. Units in this group are not going to receive any intervention. Will be only observed in their current intervention of repositioning. | Other: Conventional care<br>* Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.<br>* Other names: Control group or usual or current care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  1 month after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 month after admission |