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NCT Number: NCT04604665

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital IPS Universitaria, Medellín, Antioquia, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High frequency postural change

Other

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 names: Repositioning

Conventional care

Other

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

Other names: Control group or usual or current care

Primary outcomes

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

    Time frame: " 1 month after admission"

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

Secondary outcomes

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

    Time frame: "1 month safter admission"

    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.

  2. Security outcomes

    Time frame: "1 month after admission"

    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.

Sponsors and collaborators

Lead sponsor

Fundación Cardioinfantil Instituto de Cardiología

Other

Collaborators

  • Universidad Autónoma de Bucaramanga

Registry information

Official study title

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.

Acronym: PENFUP-2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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