Improve sleep in critically ill patients: Study protocol for a randomized controlled trial for a multi-component intervention of environment control in the ICU.

INTRODUCTION: In critically ill patients, sleep and circadian rhythms are greatly altered. These disturbances have been associated with adverse consequences, including increased mortality. Factors associated with the ICU environment, such as exposure to inadequate light and noise levels during the day and night or inflexible schedules of daily care activities, have been described as playing an essential role in sleep disturbances. The main objective of this study is to evaluate the impact of the use of a multifaceted environmental control intervention in the ICU on the quantity and quality of sleep, delirium, and post-intensive care neuropsychological impairment in critically ill patients. METHODS: This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. Patients will be randomized to receive a multifaceted intervention of environmental control in the ICU (dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities) or standard care. The protocol will be applied from enrollment until ICU discharge. Baseline parameters, light and noise levels, polysomnography and actigraphy, daily oscillation of plasma concentrations of Melatonin and Cortisol, and questionnaires for the qualitative evaluation of sleep, will be assessed during the study. In addition, all patients will undergo standardized follow-up before hospital discharge and at 6 months to evaluate neuropsychological impairment. DISCUSSION: This study is the first randomized clinical trial in critically ill patients to evaluate the effect of a multicomponent, non-pharmacological environmental control intervention on sleep improvement in ICU patients. The results will provide data about the potential synergistic effects of a combined multi-component environmental intervention in ICU on outcomes in the ICU and long term, and the mechanism of action. TRIAL REGISTRATION: ClinicalTrials.gov, NCT. Registered on January 10, 2023. Last updated on 24 Jan 2023.

The PhINEST study - Pharyngeal ICU Novel Electrical Stimulation Therapy: Study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study.

INTRODUCTION: Post-extubation dysphagia is commonly observed in ICU patients and associated with increased aspiration rates, delayed resumption of oral intake/ malnutrition, prolonged ICU and hospital length of stay, decreased quality of life, and increased mortality. Conventional therapeutic approaches are limited. Pharyngeal electrical stimulation (PES) was previously shown to improve swallowing function and airway safety in severely dysphagic tracheostomised stroke patients. METHODS: In a multi-center, single-blind, 1:1 randomized controlled study, up to 400 (360 evaluable) mixed emergency adult ICU patients with recent extubation following mechanical ventilation and confirmed oropharyngeal dysphagia will be enrolled at investigational academic ICUs. Primary objective is to evaluate the effectiveness of PES in reducing the severity of unsafe swallows. Patients will be randomized to receive PES (or sham) treatment on 3 consecutive days in addition to best supportive care. Primary endpoint is a composite of 2 endpoints with hierarchy based on clinical priorities: DISCUSSION:: This study will evaluate the effects of PES on swallowing safety in critically ill ICU patients post mechanical ventilation with oropharyngeal dysphagia.

The effect of a multidisciplinary outpatient team approach on outcomes in diabetic foot care: a single center study.

BACKGROUND: Recent studies showed no reduction in major amputation rates after introduction of a multidisciplinary team (MDT) approach for the treatment of diabetic foot ulcer. The efficacy of MDTs in the current standard of care is being questioned. This retrospective single-center study evaluated the efficacy of an outpatient MDT approach on limb salvage and ulcer healing in treating diabetic foot ulcers. METHODS: Patients with a diabetic foot ulcer treated before (2015) and after (2017) implementation of an MDT in a single center were compared. The MDT met weekly and consisted of a vascular surgeon, physiatrist, internist, shoe technician, wound care nurse, nurse practitioner, cast technician, and podiatrist. The primary outcome was limb salvage at 1 year. Secondary outcomes were ulcer healing, amputation-free survival, freedom from any amputation, and overall survival. Multivariable Cox regression models were used to assess predictors for major amputation. RESULTS: A vascular surgeon treated 104 patients with 148 ulcers in 2015, and the multidisciplinary team treated 133 patients with 188 ulcers in 2017. Limb salvage (90.9% vs. 95.5%, P=0.050), freedom from any amputation (56.5% vs. 78.0%, P<0.001), and ulcer healing (48.3% vs. 69.2%, P<0.001) were significantly lower in the non-MDT group than in the MDT group. Amputation-free survival and overall survival did not differ significantly between the groups. Predictors for major amputation were University of Texas Wound Classification 3D (hazard ratio, 2.8; 95% confidence interval, 1.17-6.45) and being treated in the non-MDT group (hazard ratio, 3.7; 95% confidence interval, 1.25-11.08). CONCLUSIONS: This retrospective study found an MDT dedicated to diabetic foot care was highly effective in increasing limb salvage and ulcer healing. We advise that such an MDT is an integrated part of the patient's chain-based care.

Plano de análise estatística para o estudo do tratamento precoce baseado em metas com utilização de uma visão fisiológica holística - estudo ANDROMEDA-SHOCK: um estudo randomizado e controlado / Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial

RESUMO Fundamentação: O estudo ANDROMEDA-SHOCK é um estudo internacional, multicêntrico, randomizado e controlado comparando ressuscitação guiada pela perfusão periférica com ressuscitação guiada pelo lactato em pacientes com choque séptico, com a finalidade de testar a hipótese de que a ressuscitação guiada pela perfusão periférica associa-se a menor morbidade e mortalidade. Objetivo: Relatar o plano de análise estatística para o estudo ANDROMEDA-SHOCK. Métodos: Descrevemos o delineamento do estudo, os objetivos primário e secundários, pacientes, métodos de randomização, intervenções, desfechos e tamanho da amostra. Descrevemos nossos planos de análise estatística para os desfechos primários, secundários e terciários. Também descrevemos as análises de subgrupos e sensibilidade. Finalmente, fornecemos detalhes para a apresentação dos resultados, inclusive modelos de tabelas para apresentar as características basais, a evolução das variáveis de hemodinâmica e perfusão, e os efeitos dos tratamentos nos desfechos. Conclusão: Segundo as melhores práticas de pesquisa, relatamos nosso plano de análise estatística e plano de gestão de dados antes do fechamento da base de dados e do início da análise dos dados. Nossa expectativa é que este procedimento previna a ocorrência de vieses na análise e incremente a utilidade dos resultados relatados.

ABSTRACT Background: ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality. Objective: To report the statistical analysis plan for the ANDROMEDA-SHOCK trial. Methods: We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes. Conclusion: According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.

Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial. / Plano de análise estatística para o estudo do tratamento precoce baseado em metas com utilização de uma visão fisiológica holística - estudo ANDROMEDA-SHOCK: um estudo randomizado e controlado.

BACKGROUND: ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality. OBJECTIVE: To report the statistical analysis plan for the ANDROMEDA-SHOCK trial. METHODS: We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes. CONCLUSION: According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.

FUNDAMENTAÇÃO: O estudo ANDROMEDA-SHOCK é um estudo internacional, multicêntrico, randomizado e controlado comparando ressuscitação guiada pela perfusão periférica com ressuscitação guiada pelo lactato em pacientes com choque séptico, com a finalidade de testar a hipótese de que a ressuscitação guiada pela perfusão periférica associa-se a menor morbidade e mortalidade. OBJETIVO: Relatar o plano de análise estatística para o estudo ANDROMEDA-SHOCK. MÉTODOS: Descrevemos o delineamento do estudo, os objetivos primário e secundários, pacientes, métodos de randomização, intervenções, desfechos e tamanho da amostra. Descrevemos nossos planos de análise estatística para os desfechos primários, secundários e terciários. Também descrevemos as análises de subgrupos e sensibilidade. Finalmente, fornecemos detalhes para a apresentação dos resultados, inclusive modelos de tabelas para apresentar as características basais, a evolução das variáveis de hemodinâmica e perfusão, e os efeitos dos tratamentos nos desfechos. CONCLUSÃO: Segundo as melhores práticas de pesquisa, relatamos nosso plano de análise estatística e plano de gestão de dados antes do fechamento da base de dados e do início da análise dos dados. Nossa expectativa é que este procedimento previna a ocorrência de vieses na análise e incremente a utilidade dos resultados relatados.

Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK-a randomized controlled trial.

BACKGROUND: Septic shock is a highly lethal condition. Early recognition of tissue hypoperfusion and its reversion are key factors for limiting progression to multiple organ dysfunction and death. Lactate-targeted resuscitation is the gold-standard under current guidelines, although it has several pitfalls including that non-hypoxic sources of lactate might predominate in an unknown proportion of patients. Peripheral perfusion-targeted resuscitation might provide a real-time response to increases in flow that could lead to a more timely decision to stop resuscitation, thus avoiding fluid overload and the risks of over-resuscitation. This article reports the rationale, study design and analysis plan of the ANDROMEDA-SHOCK Study. METHODS: ANDROMEDA-SHOCK is a randomized controlled trial which aims to determine if a peripheral perfusion-targeted resuscitation is associated with lower 28-day mortality compared to a lactate-targeted resuscitation in patients with septic shock with less than 4 h of diagnosis. Both groups will be treated with the same sequential approach during the 8-hour study period pursuing normalization of capillary refill time versus normalization or a decrease of more than 20% of lactate every 2 h. The common protocol starts with fluid responsiveness assessment and fluid loading in responders, followed by a vasopressor and an inodilator test if necessary. The primary outcome is 28-day mortality, and the secondary outcomes are: free days of mechanical ventilation, renal replacement therapy and vasopressor support during the first 28 days after randomization; multiple organ dysfunction during the first 72 h after randomization; intensive care unit and hospital lengths of stay; and all-cause mortality at 90-day. A sample size of 422 patients was calculated to detect a 15% absolute reduction in mortality in the peripheral perfusion group with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. CONCLUSIONS: If peripheral perfusion-targeted resuscitation improves 28-day mortality, this could lead to simplified algorithms, assessing almost in real-time the reperfusion process, and pursuing more physiologically sound objectives. At the end, it might prevent the risk of over-resuscitation and lead to a better utilization of intensive care unit resources. Trial registration ClinicalTrials.gov Identifier: NCT03078712 (registered retrospectively March 13th, 2017).

The Prevalence of Compassion Fatigue and Burnout among Healthcare Professionals in Intensive Care Units: A Systematic Review.

BACKGROUND: Working in the stressful environment of the Intensive Care Unit (ICU) is an emotionally charged challenge that might affect the emotional stability of medical staff. The quality of care for ICU patients and their relatives might be threatened through long-term absenteeism or a brain and skill drain if the healthcare professionals leave their jobs prematurely in order to preserve their own health. PURPOSE: The purpose of this review is to evaluate the literature related to emotional distress among healthcare professionals in the ICU, with an emphasis on the prevalence of burnout and compassion fatigue and the available preventive strategies. METHODS: A systematic literature review was conducted, using Embase, Medline OvidSP, Cinahl, Web-of-science, PsychINFO, PubMed publisher, Cochrane and Google Scholar for articles published between 1992 and June, 2014. Studies reporting the prevalence of burnout, compassion fatigue, secondary traumatic stress and vicarious trauma in ICU healthcare professionals were included, as well as related intervention studies. RESULTS: Forty of the 1623 identified publications, which included 14,770 respondents, met the selection criteria. Two studies reported the prevalence of compassion fatigue as 7.3% and 40%; five studies described the prevalence of secondary traumatic stress ranging from 0% to 38.5%. The reported prevalence of burnout in the ICU varied from 0% to 70.1%. A wide range of intervention strategies emerged from the recent literature search, such as different intensivist work schedules, educational programs on coping with emotional distress, improving communication skills, and relaxation methods. CONCLUSIONS: The true prevalence of burnout, compassion fatigue, secondary traumatic stress and vicarious trauma in ICU healthcare professionals remains open for discussion. A thorough exploration of emotional distress in relation to communication skills, ethical rounds, and mindfulness might provide an appropriate starting point for the development of further preventive strategies.