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Critical IllnessPENFUP-2NCT04604665

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

A study testing High frequency postural change and Conventional care in people with Critical Illness, run by Fundación Cardioinfantil Instituto de Cardiología at 21 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Critical Illness
What is being tested?
High frequency postural change and Conventional care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,300 participants
Where
21 sitesColombia
Study dates
10 Apr 2021to 10 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Colombia21 sites

  • Hospital Central Barranquilla

    Barranquilla, Atlántico

  • Hospital Universitario Norte Barranquilla

    Barranquilla

  • Clínica Palermo

    Bogotá, Bogota D.C., 2356

  • Hospital Militar Central

    Bogotá, Bogota D.C.

  • Hospital San José

    Bogotá, Bogota D.C.

  • Centro Policlínico de Olaya

    Bogotá, Cundinamarca

  • Clinica Nogales

    Bogotá, Cundinamarca

  • Fundación CardioInfantil Instituto de Cardiología

    Bogotá, Cundinamarca

  • Clínica de Occidente

    Bogotá

  • Clínica SHAIO

    Bogotá

  • Hospital Universitario La Samaritana

    Bogotá

  • Fundación Cardiovascular Bucaramanga

    Bucaramanga, Santander Department

  • International Hospital of Colombia -HIC

    Bucaramanga, Santander Department

  • Clìnica FOSCAL Internacional

    Bucaramanga

  • Clìnica Foscal_Carlos Ardila lulle

    Bucaramanga

  • Hospital Erasmo Meoz

    Cúcuta, Norte de Santander Department

  • Hospital Federico Lleras Acosta

    Ibague, Tolima Department

  • S.E.S Hospital Universitario de Caldas

    Manizales, Caldas Department

  • Hospital IPS Universitaria

    Medellín, Antioquia

  • Hospital San Vicente de Paul

    Medellín, Antioquia

  • Hospital San Vicente_RioNegro

    Rionegro, Antioquia

Other trials in Colombia

About this study

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.

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.

Read the 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.

Being tested
High frequency postural change, Conventional care
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High frequency postural changeOther

    Also called Repositioning

    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 careOther

    Also called Control group or usual or current care

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

Study groups in NCT04604665
Study groupRoleWhat they receive
High frequency postural changeExperimentalRepositioning 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.
Receives: Other: High frequency postural change
Conventional careActive comparatorRepositioning 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.
Receives: Other: Conventional care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: " 1 month after admission"

Secondary outcomes (2)

  1. 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.

    Measured: "1 month safter admission"

  2. 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.

    Measured: "1 month after admission"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start10 Apr 2021
  3. Primary completion10 Dec 2023
  4. Study completion10 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
3,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04604665
Sponsor's protocol ID
844-2019
Acronym
PENFUP-2
Status last verified
Jan 2024
First submitted
14 Oct 2020
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24700291

  • 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.

  • 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.

    PubMed 10983058

  • 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.

    PubMed 22819601

  • 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.

  • 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.

    PubMed 34225724

Questions about this trial

What is this clinical trial studying?

A study testing High frequency postural change and Conventional care in people with Critical Illness, run by Fundación Cardioinfantil Instituto de Cardiología at 21 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence (incidence rata ration) of new pressure ulcers in each Intensive Care Unit (ICU) (time frame: " 1 month after admission"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04604665, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.

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