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

• ClinicalTrials.gov Identifier: NCT04604665
• Recruitment Status: Completed
• First Posted: October 27, 2020
• Last Update Posted: January 22, 2024
• Sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Collaborator: Universidad Autónoma de Bucaramanga
• Information provided by (Responsible Party): Olga Cortés, RN, MSc, PhD, Fundación Cardioinfantil Instituto de Cardiología

Tracking Information

• First Submitted Date: October 14, 2020
• First Posted Date: October 27, 2020
• Last Update Posted Date: January 22, 2024
• Actual Study Start Date: April 10, 2021
• Actual Primary Completion Date: December 10, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2023)

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.

Original Primary Outcome Measures (submitted: October 21, 2020)

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.

Current Secondary Outcome Measures (submitted: October 27, 2023)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: October 21, 2020)

• Validity of the grade of pressure ulcers. [ Time Frame: "36 months" ]
  Evaluation of the validity of the classification of the stage of the lesions according to the agreement compared with experts (grade I to Iv).
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers
• 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.
• 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.
• 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
• Study Phase: Not Applicable

Study Design

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

• Condition: Critical Illness

Intervention

• 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
• 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

Study Arms

• 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.
  Intervention: Other: High frequency postural change
• 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.
  Intervention: Other: Conventional care

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2020): 3300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 10, 2023
• Actual Primary Completion Date: December 10, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.
• Covid patients or other patients exposed to different mobilization patterns (e.g., 12 hours prone vs 12 supine)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia

Administrative Information

• NCT Number: NCT04604665
• Other Study ID Numbers: 844-2019
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Olga Cortés, RN, MSc, PhD, Fundación Cardioinfantil Instituto de Cardiología
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundación Cardioinfantil Instituto de Cardiología
• Original Study Sponsor: Same as current
• Collaborators: Universidad Autónoma de Bucaramanga

Investigators

• Principal Investigator: Olga L Cortés, PhD; Fundación Cardioinfantil Instituto de Cardiología

• PRS Account: Fundación Cardioinfantil Instituto de Cardiología
• Verification Date: January 2024