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Early Mobilization Interventions in the Intensive Care Unit: Ongoing and Unpublished Randomized Trials.

ABSTRACT: Background:Critical care societies recommend early mobilization (EM) as standard practice in the intensive care unit (ICU) setting. However, there is limited randomized controlled trial (RCT) evidence supporting EM's effectiveness. Our objective was to identify ongoing or completed RCTs assessing EM's effectiveness in the ICU. Method:We searched ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry for ongoing or completed but not published RCTs in an ICU setting with objective outcome measures. Results:There were 14 RCTs included in the analysis. All studies were in the general or mixed ICU setting (N=14). Half of the studies (N=7) were small RCTs (<100 projected participants) and half (N=7) were medium-sized RCTs (100-999 participants). Inclusion criteria included mechanical ventilation use or expected use (N=13) and prehospital functional status (N=7). Primary EM interventions were standard physiotherapist-based activities (N=4), cycling (N=9), and electrical muscle stimulation (N=1). Only one study involved nurse-led EM. The most common assessment tool was the 6-minute walk test (N=6). Primary outcome measures were physiological (N=3), clinical (N=3), patient-centered (N=7), and healthcare resource use (N=1). Most studies (N=8) involved post-ICU follow-up measures up to 1-year posthospitalization. There were no studies targeting older adults or people with acute cardiac disease. Conclusion:Identified studies will further the evidence base for EM's effectiveness. There is a need for studies looking at specific patient populations that may benefit from EM, such as older adults and cardiac patients, as well as for novel EM delivery strategies, such as nurse-led EM.

SUBMITTER: Maheswaran J

PROVIDER: S-EPMC7201471 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Early Mobilization Interventions in the Intensive Care Unit: Ongoing and Unpublished Randomized Trials.

Maheswaran Janane J Fromowitz Jake J Goldfarb Michael M

Critical care research and practice 20200121

<h4>Background</h4>Critical care societies recommend early mobilization (EM) as standard practice in the intensive care unit (ICU) setting. However, there is limited randomized controlled trial (RCT) evidence supporting EM's effectiveness. Our objective was to identify ongoing or completed RCTs assessing EM's effectiveness in the ICU.<h4>Method</h4>We searched ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry for ongoing or completed but not published RCTs in an ICU sett ...[more]

PMID: 32399292

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Project description:The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education.On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers.We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%).Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.

Project description:BackgroundTimely recognition of hemodynamic instability in critically ill patients enables increased vigilance and early treatment opportunities. We develop the Hemodynamic Stability Index (HSI), which highlights situational awareness of possible hemodynamic instability occurring at the bedside and to prompt assessment for potential hemodynamic interventions.MethodsWe used an ensemble of decision trees to obtain a real-time risk score that predicts the initiation of hemodynamic interventions an hour into the future. We developed the model using the eICU Research Institute (eRI) database, based on adult ICU admissions from 2012 to 2016. A total of 208,375 ICU stays met the inclusion criteria, with 32,896 patients (prevalence = 18%) experiencing at least one instability event where they received one of the interventions during their stay. Predictors included vital signs, laboratory measurements, and ventilation settings.ResultsHSI showed significantly better performance compared to single parameters like systolic blood pressure and shock index (heart rate/systolic blood pressure) and showed good generalization across patient subgroups. HSI AUC was 0.82 and predicted 52% of all hemodynamic interventions with a lead time of 1-h with a specificity of 92%. In addition to predicting future hemodynamic interventions, our model provides confidence intervals and a ranked list of clinical features that contribute to each prediction. Importantly, HSI can use a sparse set of physiologic variables and abstains from making a prediction when the confidence is below an acceptable threshold.ConclusionsThe HSI algorithm provides a single score that summarizes hemodynamic status in real time using multiple physiologic parameters in patient monitors and electronic medical records (EMR). Importantly, HSI is designed for real-world deployment, demonstrating generalizability, strong performance under different data availability conditions, and providing model explanation in the form of feature importance and prediction confidence.

Project description:BACKGROUND:Physical therapy can prevent functional impairments and improve the quality of life of patients after hospital discharge. However, the effect of early mobilization on patients with a critical illness remains unclear. This study was performed to assess the evidence available regarding the effect of early mobilization on critically ill patients in the intensive care unit (ICU). METHODS:Electronic databases were searched from their inception to March 21, 2019. Randomized controlled trials (RCTs) comprising critically ill patients who received early mobilization were included. The methodological quality and risk of bias of each eligible trial were assessed using the Cochrane Collaboration tool. Data were extracted using a standard collection form each included study, and processed using the Mantel-Haenszel (M-H) or inverse-variance (I-V) test in the STATA v12.0 statistical software. RESULTS:A total of 1,898 records were screened. Twenty-three RCTs comprising 2,308 critically ill patients were ultimately included. Early mobilization decreased the incidence of ICU-acquired weakness (ICU-AW) at hospital discharge (three studies, 190 patients, relative risk (RR): 0.60, 95% confidence interval (CI) [0.40, 0.90]; p = 0.013, I2 = 0.0%), increased the number of patients who were able to stand (one study, 50 patients, 90% vs. 62%, p = 0.02), increased the number of ventilator-free days (six studies, 745 patients, standardized mean difference (SMD): 0.17, 95% CI [0.02, 0.31]; p = 0.023, I2 = 35.5%) during hospitalization, increased the distance the patient was able to walk unassisted (one study, 104 patients, 33.4 (0-91.4) meters vs. 0 (0-30.4) meters, p = 0.004) at hospital discharge, and increased the discharged-to-home rate (seven studies, 793 patients, RR: 1.16, 95% CI [1.00, 1.34]; p = 0.046). The mortality (28-day, ICU and hospital) and adverse event rates were moderately increased by early mobilization, but the differences were statistically non-significant. However, due to the substantial heterogeneity among the included studies, and the low quality of the evidence, the results of this study should be interpreted with caution. Publication bias was not identified. CONCLUSIONS:Early mobilization appears to decrease the incidence of ICU-AW, improve the functional capacity, and increase the number of ventilator-free days and the discharged-to-home rate for patients with a critical illness in the ICU setting.

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Early Mobilization Interventions in the Intensive Care Unit: Ongoing and Unpublished Randomized Trials.

Publications

Early Mobilization Interventions in the Intensive Care Unit: Ongoing and Unpublished Randomized Trials.

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