Clincosm LogoSign in Get a demo

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

Sponsor
Fundación Cardioinfantil Instituto de Cardiología (Other)
Overall Status
Recruiting
CT.gov ID
NCT04604665
Collaborator
Universidad Autónoma de Bucaramanga (Other)
3,300
Enrollment
13
Locations
2
Arms
28.7
Anticipated Duration (Months)
253.8
Patients Per Site
8.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High frequency postural change
  • Other: Conventional care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
3300 participants
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.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
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.
Actual Study Start Date :
Apr 10, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Repositioning

    		•
    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.

    Other: Conventional care
    Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.
    Other Names:
  • Control group or usual or current care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of new pressure ulcers in each Intensive Care Unit (ICU) ["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.

    Secondary Outcome Measures

    1. Risk index (HR) and time to event of Pressure ulcers of the patients ["36 months"]

      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.

    2. Security outcomes ["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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital IPS Universitaria Medellín Antioquia Colombia
    2 Hospital San Vicente de Paul Medellín Antioquia Colombia
    3 Hospital San Vicente_RioNegro Rionegro Antioquia Colombia
    4 Hospital Central Barranquilla Barranquilla Atlántico Colombia
    5 S.E.S Hospital Universitario de Caldas Manizales Caldas Colombia
    6 Fundación CardioInfantil Instituto de Cardiología Bogotá Cundinamarca Colombia
    7 Hospital Erasmo Meoz Cúcuta Norte De Santander Colombia
    8 Hospital Federico Lleras Acosta Ibagué Tolima Colombia
    9 Clínica de Occidente Bogotá Colombia
    10 Clínica SHAIO Bogotá Colombia
    11 Hospital Universitario La Samaritana Bogotá Colombia
    12 Clìnica FOSCAL Internacional Bucaramanga Colombia
    13 Clìnica Foscal_Carlos Ardila lulle Bucaramanga Colombia

    Sponsors and Collaborators

    • Fundación Cardioinfantil Instituto de Cardiología
    • Universidad Autónoma de Bucaramanga

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Olga Cortés, RN, MSc, PhD, Reseear Associated, Research Department, Principal Investigator, Fundación Cardioinfantil Instituto de Cardiología
    ClinicalTrials.gov Identifier:
    NCT04604665
    Other Study ID Numbers:
    • 844-2019
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pressure Ulcer
    Critical Illness

    Study Results

    No Results Posted as of Jul 19, 2022