Clinical trial NCT04604665: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
Collaborators: name: Universidad Autónoma de Bucaramanga
First posted: 2020-10-27
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: The incidence (incidence rata ration) of new pressure ulcers in each Intensive Care Unit (ICU)
timeFrame: " 1 month after admission"
Secondary outcomes:
measure: Risk index (HR) and time to event of Pressure ulcers of the patients
timeFrame: "1 month safter admission"
measure: Security outcomes
timeFrame: "1 month after admission"
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Hospital IPS Universitaria
state: Antioquia
city: Medellín
country: Colombia
facility: Hospital San Vicente de Paul
state: Antioquia
city: Rionegro
country: Colombia
facility: Hospital San Vicente_RioNegro
state: Antioquia
city: Barranquilla
country: Colombia
facility: Hospital Central Barranquilla
state: Atlántico
city: Bogotá
country: Colombia
facility: Clínica Palermo
state: Bogotá D.C
city: Bogotá
country: Colombia
facility: Hospital Militar Central
state: Bogotá D.C
city: Bogotá
country: Colombia
facility: Hospital San José
state: Bogotá D.C
city: Manizales
country: Colombia
facility: S.E.S Hospital Universitario de Caldas
state: Caldas
city: Bogotá
country: Colombia
facility: Centro Policlínico de Olaya
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Clinica Nogales
state: Cundinamarca
city: Bogotá
country: Colombia
facility: Fundación CardioInfantil Instituto de Cardiología
state: Cundinamarca
city: Cúcuta
country: Colombia
facility: Hospital Erasmo Meoz
state: Norte De Santander
city: Bucaramanga
country: Colombia
facility: Fundación Cardiovascular Bucaramanga
state: Santander
city: Bucaramanga
country: Colombia
facility: International Hospital of Colombia -HIC
state: Santander
city: Ibagué
country: Colombia
facility: Hospital Federico Lleras Acosta
state: Tolima
city: Barranquilla
country: Colombia
facility: Hospital Universitario Norte Barranquilla
city: Bogotá
country: Colombia
facility: Clínica de Occidente
city: Bogotá
country: Colombia
facility: Clínica SHAIO
city: Bogotá
country: Colombia
facility: Hospital Universitario La Samaritana
city: Bucaramanga
country: Colombia
facility: Clìnica FOSCAL Internacional
city: Bucaramanga
country: Colombia
facility: Clìnica Foscal_Carlos Ardila lulle
Study officials:
affiliation: Fundación Cardioinfantil Instituto de Cardiología
name: Olga L Cortés, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
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.
citation: 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.