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

NCT04604665 | Completed DMC

• 1 other identifier: 844-2019
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 21

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Risk index (HR) and time to event of Pressure ulcers of the patients

  "1 month safter admission"

• Security outcomes

  "1 month after admission"

Study Arms (2)

High frequency postural change

EXPERIMENTAL

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

Conventional care

ACTIVE COMPARATOR

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

Interventions

High frequency postural change OTHER

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.

Also known as: Repositioning

High frequency postural change

Conventional care OTHER

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

Also known as: Control group or usual or current care

Conventional care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead
• Universidad Autónoma de Bucaramanga: collaborator

Study Sites (21)

Hospital IPS Universitaria

Medellín, Antioquia, Colombia

Location

Hospital San Vicente de Paul

Medellín, Antioquia, Colombia

Location

Hospital San Vicente_RioNegro

Rionegro, Antioquia, Colombia

Location

Hospital Central Barranquilla

Barranquilla, Atlántico, Colombia

Location

Clínica Palermo

Bogotá, Bogota D.C., 2356, Colombia

Location

Hospital Militar Central

Bogotá, Bogota D.C., Colombia

Location

Hospital San José

Bogotá, Bogota D.C., Colombia

Location

S.E.S Hospital Universitario de Caldas

Manizales, Caldas Department, Colombia

Location

Centro Policlínico de Olaya

Bogotá, Cundinamarca, Colombia

Location

Clinica Nogales

Bogotá, Cundinamarca, Colombia

Location

Fundación CardioInfantil Instituto de Cardiología

Bogotá, Cundinamarca, Colombia

Location

Hospital Erasmo Meoz

Cúcuta, Norte de Santander Department, Colombia

Location

Fundación Cardiovascular Bucaramanga

Bucaramanga, Santander Department, Colombia

Location

International Hospital of Colombia -HIC

Bucaramanga, Santander Department, Colombia

Location

Hospital Federico Lleras Acosta

Ibagué, Tolima Department, Colombia

Location

Hospital Universitario Norte Barranquilla

Barranquilla, Colombia

Location

Clínica de Occidente

Bogotá, Colombia

Location

Clínica SHAIO

Bogotá, Colombia

Location

Hospital Universitario La Samaritana

Bogotá, Colombia

Location

Clìnica FOSCAL Internacional

Bucaramanga, Colombia

Location

Clìnica Foscal_Carlos Ardila lulle

Bucaramanga, Colombia

Location

Related Publications (6)

• 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.

  PMID: 24700291 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10983058 BACKGROUND

• 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.

  PMID: 22819601 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34225724 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Olga L Cortés, PhD

  Fundación Cardioinfantil Instituto de Cardiología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Telephone randomization Random numbers centers Blinded for analyst and researchers
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reseear Associated, Research Department, Principal Investigator

Model Details: Clinical trial, randomized, pragmatic, of parallel groups (1: 1), by clusters, blinded for the collection of information, sending, and in the evaluation of outcomes.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 27, 2020
• Study Start: April 10, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (21)