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

Critical Illness Clinical Trial

— PENFUP-2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604665
• Other study ID #: 844-2019
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: December 10, 2023

Study information

• Verified date: January 2024
• Source: Fundación Cardioinfantil Instituto de Cardiología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3300
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Pressure Ulcer

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Cardioinfantil Instituto de Cardiología	Universidad Autónoma de Bucaramanga

Country where clinical trial is conducted

Colombia, 

References & Publications (5)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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"
Secondary	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"