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

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.

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: High frequency postural change; Other: Conventional care

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 Type: Interventional
• Enrollment (Actual): 3300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga L Cortés, RN,MSc,PhD; Phone Number: 7321 571 667 2727; Email: olgacortesf@gmail.com
• Study Contact Backup: Name: Karen Moreno, MSc; Phone Number: 571 667 2727; Email: kmoreno@cardioinfantil.org

Study Locations

• Colombia
  • Barranquilla, Colombia
    • Hospital Universitario Norte Barranquilla
  • Bogotá, Colombia
    • Clínica SHAIO
  • Bogotá, Colombia
    • Clínica de Occidente
  • Bogotá, Colombia
    • Hospital Universitario La Samaritana
  • Bucaramanga, Colombia
    • Clìnica FOSCAL Internacional
  • Bucaramanga, Colombia
    • Clìnica Foscal_Carlos Ardila lulle
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Hospital IPS Universitaria
    • Medellín, Antioquia, Colombia
      • Hospital San Vicente de Paúl
    • Rionegro, Antioquia, Colombia
      • Hospital San Vicente_RioNegro
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • Hospital Central Barranquilla
  • Bogotá D.C
    • Bogotá, Bogotá D.C, Colombia, 2356
      • Clínica Palermo
    • Bogotá, Bogotá D.C, Colombia
      • Hospital Militar Central
    • Bogotá, Bogotá D.C, Colombia
      • Hospital San José
  • Caldas
    • Manizales, Caldas, Colombia
      • S.E.S Hospital Universitario de Caldas
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Fundación CardioInfantil Instituto de Cardiología
    • Bogotá, Cundinamarca, Colombia
      • Centro Policlínico de Olaya
    • Bogotá, Cundinamarca, Colombia
      • Clinica Nogales
  • Norte De Santander
    • Cúcuta, Norte De Santander, Colombia
      • Hospital Erasmo Meoz
  • Santander
    • Bucaramanga, Santander, Colombia
      • Fundación Cardiovascular Bucaramanga
    • Bucaramanga, Santander, Colombia
      • International Hospital of Colombia -HIC
  • Tolima
    • Ibagué, Tolima, Colombia
      • Hospital Federico Lleras Acosta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Control group or usual or current care

What is the study measuring?

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"

Collaborators and Investigators

• Sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Collaborators: Universidad Autónoma de Bucaramanga
• Investigators: Principal Investigator: Olga L Cortés, PhD, Fundación CardioInfantil Instituto de Cardiología

Publications and helpful links

General Publications

• Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD009958. doi: 10.1002/14651858.CD009958.pub2.
• 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.
• Hawkins S, Stone K, Plummer L. An holistic approach to turning patients. Nurs Stand. 1999 Oct 6-12;14(3):51-6. doi: 10.7748/ns1999.10.14.3.51.c2689.
• Burk RS, Grap MJ. Backrest position in prevention of pressure ulcers and ventilator-associated pneumonia: conflicting recommendations. Heart Lung. 2012 Nov-Dec;41(6):536-45. doi: 10.1016/j.hrtlng.2012.05.008. Epub 2012 Jul 21.
• 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.
• Cortes OL, Herrera-Galindo M, Villar JC, Rojas YA, Del Pilar Paipa M, Salazar L. Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial. BMC Nurs. 2021 Jul 5;20(1):121. doi: 10.1186/s12912-021-00616-0.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Skin Ulcer; Critical Illness; Pressure Ulcer
• Other Study ID Numbers: 844-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No