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| Name | Class |
|---|---|
| Universidad Autónoma de Bucaramanga | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | "1 month safter admission" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga L Cortés, PhD | Fundación Cardioinfantil Instituto de Cardiología | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital IPS Universitaria | Medellín | Antioquia | Colombia | |||
| Hospital San Vicente de Paul |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24700291 | Background | 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. | |
| 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. | ||
| 10983058 |
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Clinical trial, randomized, pragmatic, of parallel groups (1: 1), by clusters, blinded for the collection of information, sending, and in the evaluation of outcomes.
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Telephone randomization Random numbers centers Blinded for analyst and researchers
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| Conventional care | Other | Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients. |
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| 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. |
| "1 month after admission" |
| Medellín |
| Antioquia |
| Colombia |
| Hospital San Vicente_RioNegro | Rionegro | Antioquia | Colombia |
| Hospital Central Barranquilla | Barranquilla | Atlántico | Colombia |
| Clínica Palermo | Bogotá | Bogota D.C. | 2356 | Colombia |
| Hospital Militar Central | Bogotá | Bogota D.C. | Colombia |
| Hospital San José | Bogotá | Bogota D.C. | Colombia |
| S.E.S Hospital Universitario de Caldas | Manizales | Caldas Department | Colombia |
| Centro Policlínico de Olaya | Bogotá | Cundinamarca | Colombia |
| Clinica Nogales | Bogotá | Cundinamarca | Colombia |
| Fundación CardioInfantil Instituto de Cardiología | Bogotá | Cundinamarca | Colombia |
| Hospital Erasmo Meoz | Cúcuta | Norte de Santander Department | Colombia |
| Fundación Cardiovascular Bucaramanga | Bucaramanga | Santander Department | Colombia |
| International Hospital of Colombia -HIC | Bucaramanga | Santander Department | Colombia |
| Hospital Federico Lleras Acosta | Ibague | Tolima Department | Colombia |
| Hospital Universitario Norte Barranquilla | Barranquilla | Colombia |
| Clínica de Occidente | Bogotá | Colombia |
| Clínica SHAIO | Bogotá | Colombia |
| Hospital Universitario La Samaritana | Bogotá | Colombia |
| Clìnica FOSCAL Internacional | Bucaramanga | Colombia |
| Clìnica Foscal_Carlos Ardila lulle | Bucaramanga | Colombia |
| 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. |
| 22819601 | 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. |
| 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. |
| 34225724 | Derived | 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. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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