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

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ClinicalTrials.gov Identifier: NCT04604665
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : December 23, 2022
Sponsor:
Collaborator:
Universidad Autónoma de Bucaramanga
Information provided by (Responsible Party):
Olga Cortés, RN, MSc, PhD, Fundación Cardioinfantil Instituto de Cardiología

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: High frequency postural change Other: Conventional care Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Telephone randomization Random numbers centers Blinded for analyst and researchers
Primary Purpose: Other
Official 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.
Actual Study Start Date : April 10, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arms and Interventions
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Arm Intervention/treatment
Experimental: High frequency postural change
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
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 Name: Repositioning
Active Comparator: Conventional care
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
Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.
Other Name: Control group or usual or current care


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of new pressure ulcers in each Intensive Care Unit (ICU) [ Time Frame: "36 months" ]
    The number of pressure injuries at any stage, new acquired in the ICU after admission per 1,000 patient days in the ICU.


Secondary Outcome Measures :
  1. Risk index (HR) and time to event of Pressure ulcers of the patients [ Time Frame: "36 months" ]
    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: "36 months" ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604665


Contacts
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Contact: Olga L Cortés, RN,MSc,PhD 571 667 2727 ext 7321 olgacortesf@gmail.com
Contact: Karen Moreno, MSc 571 667 2727 kmoreno@cardioinfantil.org

Locations
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Sponsors and Collaborators
Fundación Cardioinfantil Instituto de Cardiología
Universidad Autónoma de Bucaramanga
Investigators
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Principal Investigator: Olga L Cortés, PhD Fundación Cardioinfantil Instituto de Cardiología
More Information
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Publications:
Ulrika Källman. (2015). Evaluation of Repositioning in Pressure Ulcer Prevention. Linköping University Medical Dissertations No. 1455. Division of Nursing science Department of Medical and Health Sciences. Linköping University, Sweden.
Eldridge S., Kerry S. Designing interventions in: A practical guide to cluster randomized trials in health services research. Page 44-57. Centre for Primary Care and Public Health, Barts, and The London School of Medicine and Dentistry, Queen Mary University of London UK. 2012 John Wiley & Sons, Ltda.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Olga Cortés, RN, MSc, PhD, Reseear Associated, Research Department, Principal Investigator, Fundación Cardioinfantil Instituto de Cardiología
ClinicalTrials.gov Identifier: NCT04604665    
Other Study ID Numbers: 844-2019
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pressure Ulcer
Critical Illness
Disease Attributes
 Pathologic Processes
Skin Ulcer
Skin Diseases