Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers (PENFUP-2)

Fundación Cardioinfantil Instituto de Cardiología

Status: Completed

Conditions: Critical Illness

Treatments: Other: Conventional care; Other: High frequency postural change

Study type: Interventional

Funder types: Other

Identifiers

NCT04604665

844-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,300 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,300 participants in 2 patient groups

High frequency postural change

Experimental group

Description:

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.

Treatment:

Other: High frequency postural change

Conventional care

Active Comparator group

Description:

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.

Treatment:

Other: Conventional care