Dataset Information

Pressure Ulcer Monitoring Platform-A Prospective, Human Subject Clinical Study to Validate Patient Repositioning Monitoring Device to Prevent Pressure Ulcers.

ABSTRACT: Objective: The objective of this prospective clinical study was to validate two prototype pressure ulcer monitoring platform (PUMP) devices, (PUMP1 and PUMP2), to promote optimal bed repositioning of hospitalized patients to prevent pressure ulcers (PUs). Approach: PUMP1 was a wearable electronic device attached to the patient gown with no skin contact. PUMP2 was a set of four identical electronic devices placed under the patient's bed wheels. A video camera recorded events in the patient room while measurements from the PUMP devices were correlated with true patient repositioning activity. The performance of these PUMP devices developed by our research team were evaluated and compared by both clinicians and engineers. Results: Ten mobility-restricted patients were enrolled into the study. Repositioning movement was recorded by both PUMP devices for 10?±?2?h and corroborated with video capture. One hundred thirty-seven movements in total were detected by both PUMP1 and PUMP2 over 105?h of capture. Two false positives were detected by the sensors and 11 movements were missed by the sensors. PUMP1 and PUMP2 never conflicted in data collection. Innovation: The presented study evaluated two different sensors' abilities to capture accurate patient repositioning to eventually prevent PU formation. Importantly, detection of patient motion was completed without contact to patient skin. Conclusion: The clinical study demonstrated successful capture of patient repositioning movement by both PUMP1 and PUMP2 devices with 85% reliability, 2 false positives, and 11 missed movements. In future studies, the PUMP devices will be combined with a SMS-based mobile phone alert system to improve caregiver repositioning behavior.

SUBMITTER: Minteer DM

PROVIDER: S-EPMC6922059 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Pressure Ulcer Monitoring Platform-A Prospective, Human Subject Clinical Study to Validate Patient Repositioning Monitoring Device to Prevent Pressure Ulcers.

Minteer Danielle M DM Simon Patsy P Taylor Donald P DP Jia Wenyan W Li Yuecheng Y Sun Mingui M Rubin J Peter JP

Advances in wound care 20191206 1

<b>Objective:</b> The objective of this prospective clinical study was to validate two prototype pressure ulcer monitoring platform (PUMP) devices, (PUMP1 and PUMP2), to promote optimal bed repositioning of hospitalized patients to prevent pressure ulcers (PUs). <b>Approach:</b> PUMP1 was a wearable electronic device attached to the patient gown with no skin contact. PUMP2 was a set of four identical electronic devices placed under the patient's bed wheels. A video camera recorded events in the ...[more]

PMID: 31871828

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Project description:BackgroundDespite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals.MethodsA nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study.ConclusionThis study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk.Trial registrationPENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.

Project description:IntroductionPressure ulcers are serious and potentially life-threatening problems across all age groups and across all medical specialties and care settings. The hospitalised elderly population is the most common group to develop pressure ulcers. This study aims to systematically review studies implementing pressure ulcer prevention strategies recommended in the Pressure Ulcer Prevention Practice Guidelines for the prevention of pressure ulcers among hospitalised elderly patients globally.Methods and analysisA systematic review of all studies that have assessed the use of pressure ulcer prevention strategies in hospital settings among hospitalised elderly patients shall be conducted. A comprehensive search of all published articles in Medline Ovid, Cumulative Index to Nursing and Allied Health Literature, PubMed, Embase, Cochrane library, Scopus and Web of Science will be done using terms such as pressure ulcers, prevention strategies, elderly patients and hospital. Studies will be screened for eligibility through title, abstract and full text by two independent reviewers. Study quality and risk of bias will be assessed using the Joanna Briggs Institute for Meta-Analysis of Statistics Assessment and Review Instrument. If sufficient data are available, a meta-analysis will be conducted to synthesise the effect size reported as OR with 95% CIs using both fixed and random effect models. I2 statistics and visual inspection of the forest plots will be used to assess heterogeneity and identify the potential sources of heterogeneity. Publication bias will be assessed by visual inspections of funnel plots and Egger's test.Ethics and disseminationNo formal ethical approval or consent is required as no primary data will be collected. We aim to publish the research findings in a peer-reviewed scientific journal to promote knowledge transfer, as well as in conferences, seminars, congresses or symposia in a traditional manner.Prospero registration numberCRD42019129088.

Project description:BackgroundPressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention costs, making prevention-focused protocols critical. Current PrU prevention protocols recommend repositioning residents at moderate, high, and severe risk every 2 h. The advent of visco-elastic (VE) high-density foam support-surfaces over the past decade may now make it possible to extend the repositioning interval to every 3 or 4 h without increasing PrU development. The TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study aims to determine: 1) whether repositioning interval can be extended for NH residents without compromising PrU incidence and 2) how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development.MethodsIn this proposed cluster randomized study, 9 NHs will be randomly assigned to one of three repositioning intervals (2, 3, or 4 h) for a 4-week period. Each enrolled site will use a single NH-wide repositioning interval as the standard of care for residents at low, moderate, and high risk of PrU development (N = 951) meeting the following criteria: minimum 3-day stay, without PrUs, no adhesive allergy, and using VE support surfaces (mattresses). An FDA-cleared patient monitoring system that records position/movement of these residents via individual wireless sensors will be used to visually cue staff when residents need repositioning and document compliance with repositioning protocols.DiscussionThis study will advance knowledge about repositioning frequency and clinically assessed PrU risk level in relation to PrU incidence and medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.Trial registrationClinical Trial Registration: NCT02996331 .

Dataset Information

Pressure Ulcer Monitoring Platform-A Prospective, Human Subject Clinical Study to Validate Patient Repositioning Monitoring Device to Prevent Pressure Ulcers.

Publications

Pressure Ulcer Monitoring Platform-A Prospective, Human Subject Clinical Study to Validate Patient Repositioning Monitoring Device to Prevent Pressure Ulcers.

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