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

Primary Purpose

Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High frequency postural change
Conventional care
Sponsored by
Fundación Cardioinfantil Instituto de Cardiología
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital IPS Universitaria
  • Hospital San Vicente de Paul
  • Hospital San Vicente_RioNegroRecruiting
  • Hospital Central Barranquilla
  • Clínica PalermoRecruiting
  • Hospital Militar CentralRecruiting
  • Hospital San JoséRecruiting
  • S.E.S Hospital Universitario de Caldas
  • Centro Policlínico de OlayaRecruiting
  • Clinica Nogales
  • Fundación CardioInfantil Instituto de CardiologíaRecruiting
  • Hospital Erasmo Meoz
  • Fundación Cardiovascular BucaramangaRecruiting
  • International Hospital of Colombia -HICRecruiting
  • Hospital Federico Lleras AcostaRecruiting
  • Clínica de Occidente
  • Clínica SHAIORecruiting
  • Hospital Universitario La SamaritanaRecruiting
  • Clìnica FOSCAL Internacional
  • Clìnica Foscal_Carlos Ardila lulle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High frequency postural change

Conventional care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence 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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 14, 2020
Last Updated
December 21, 2022
Sponsor
Fundación Cardioinfantil Instituto de Cardiología
Collaborators
Universidad Autónoma de Bucaramanga
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1. Study Identification

Unique Protocol Identification Number
NCT04604665
Brief Title
Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Cardioinfantil Instituto de Cardiología
Collaborators
Universidad Autónoma de Bucaramanga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
Telephone randomization Random numbers centers Blinded for analyst and researchers
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High frequency postural change
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional care
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
High frequency postural change
Other Intervention Name(s)
Repositioning
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional care
Other Intervention Name(s)
Control group or usual or current care
Intervention Description
Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.
Primary Outcome Measure Information:
Title
The incidence of new pressure ulcers in each Intensive Care Unit (ICU)
Description
The number of pressure injuries at any stage, new acquired in the ICU after admission per 1,000 patient days in the ICU.
Time Frame
"36 months"
Secondary Outcome Measure Information:
Title
Risk index (HR) and time to event of Pressure ulcers of the patients
Description
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.
Time Frame
"36 months"
Title
Security outcomes
Description
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.
Time Frame
"36 months"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga L Cortés, RN,MSc,PhD
Phone
571 667 2727
Ext
7321
Email
olgacortesf@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Moreno, MSc
Phone
571 667 2727
Email
kmoreno@cardioinfantil.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga L Cortés, PhD
Organizational Affiliation
Fundación Cardioinfantil Instituto de Cardiología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital IPS Universitaria
City
Medellín
State/Province
Antioquia
Country
Colombia
Individual Site Status
Completed
Facility Name
Hospital San Vicente de Paul
City
Medellín
State/Province
Antioquia
Country
Colombia
Individual Site Status
Completed
Facility Name
Hospital San Vicente_RioNegro
City
Rionegro
State/Province
Antioquia
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Velasquez, RN
Email
sandra.velasquez@sansandra.velasquez@sanvicentefundacion.com
Facility Name
Hospital Central Barranquilla
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Individual Site Status
Completed
Facility Name
Clínica Palermo
City
Bogotá
State/Province
Bogotá D.C
ZIP/Postal Code
2356
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Cabezas, RN, Spc
Phone
3103134088
Email
rocio.cabezas@clinicapalermo.com.co
Facility Name
Hospital Militar Central
City
Bogotá
State/Province
Bogotá D.C
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Silva, RN, Director
Phone
3143351746
Email
csilva@homil.gov.co
Facility Name
Hospital San José
City
Bogotá
State/Province
Bogotá D.C
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita M Pérez Pérez, RN, Spc
Facility Name
S.E.S Hospital Universitario de Caldas
City
Manizales
State/Province
Caldas
Country
Colombia
Individual Site Status
Completed
Facility Name
Centro Policlínico de Olaya
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Navarro, RN
Phone
3138866158
Email
Terf_johanan@cpo.com
Facility Name
Clinica Nogales
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Enrique Zapata, RN
Phone
3124498239
Email
nelsonzc@clinicanogales.com.co
Facility Name
Fundación CardioInfantil Instituto de Cardiología
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María del Pilar Paipa, RN
Email
mpaipa@lacardio.org
Facility Name
Hospital Erasmo Meoz
City
Cúcuta
State/Province
Norte De Santander
Country
Colombia
Individual Site Status
Completed
Facility Name
Fundación Cardiovascular Bucaramanga
City
Bucaramanga
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruby Dueñas, RN
Phone
3176479173
Email
ruby0612@gmail.com
Facility Name
International Hospital of Colombia -HIC
City
Bucaramanga
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Mora, RN
Phone
3188269427
Email
Imorarico@hotmail.com
Facility Name
Hospital Federico Lleras Acosta
City
Ibagué
State/Province
Tolima
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johana Garzón, RN
Email
yohanamilena.garzomrodriguez@gmail.com
Facility Name
Clínica de Occidente
City
Bogotá
Country
Colombia
Individual Site Status
Completed
Facility Name
Clínica SHAIO
City
Bogotá
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Gutierrez, RN
Email
sandra.gutierrez@shaio.org
Facility Name
Hospital Universitario La Samaritana
City
Bogotá
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Harvey Jaimes, RN
Email
enfermeria.jefe14@hus.org.co
Facility Name
Clìnica FOSCAL Internacional
City
Bucaramanga
Country
Colombia
Individual Site Status
Completed
Facility Name
Clìnica Foscal_Carlos Ardila lulle
City
Bucaramanga
Country
Colombia
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24700291
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
10983058
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.
Results Reference
background
PubMed Identifier
22819601
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
34225724
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.
Results Reference
derived

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

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