ABSTRACT
The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710.
Subject(s)
COVID-19 , Telemedicine , Humans , Child , SARS-CoV-2 , Hospitalization , Intensive Care Units, Pediatric , Randomized Controlled Trials as TopicABSTRACT
ABSTRACT The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710
RESUMO O objetivo deste estudo será apresentar o protocolo de um ensaio clínico randomizado em cluster a ser realizado por meio do projeto TeleUTI - Qualificação da Assistência em Terapia Intensiva por Telemedicina. O estudo consistirá em um ensaio clínico randomizado por cluster, open label, em unidades de terapia intensiva pediátricas, com proporção de alocação de 1:1, com o intuito de comparar o grupo de intervenção (apoio da telemedicina para os pacientes internados na unidade de terapia intensiva pediátrica) com um grupo controle (cuidados habituais da unidade de terapia intensiva pediátrica). O estudo se propõe a selecionar 16 unidades de terapia intensiva pediátricas, incluindo 100 participantes por local, com o total de 1.600 participantes. O grupo intervenção receberá telerounds de segunda-feira a sexta-feira e terá à disposição especialistas e atividades de educação continuada. O desfecho primário a ser avaliado será o tempo de permanência nas unidades de terapia intensiva pediátricas, definido pela diferença entre a data de alta do participante com a data de admissão na unidade de terapia intensiva. Os desfechos secundários serão: taxa de mortalidade; dias livres de ventilação mecânica, dias de uso de antibióticos, dias de uso de drogas vasoativas e dias de uso de sedoanalgesia. Este estudo será conduzido em conformidade com a resolução 466/12 do Conselho Nacional de Saúde, com aprovação pelo Comitê de Ética em Pesquisa das instituições hospitalares envolvidas. O trabalho tem o potencial de reproduzir estudos sobre Telemedicina em cuidados intensivos, podendo trazer contribuições importantes ao atendimento em unidades de terapia intensiva no Brasil e em outras realidades. Se a Telemedicina mostrar resultados clínicos assistenciais positivos em relação ao tratamento convencional, mais pacientes pediátricos poderão ser beneficiados. Registro ClinicalTrials.gov: NCT05260710
ABSTRACT
The use of telemedicine in ICUs has grown and is becoming increasingly recognized. However, its impact on PICUs remains unclear. This systematic review and meta-analysis aimed to evaluate whether telemedicine in the PICU has the potential to improve clinical and non-clinical outcomes. PubMed, Scopus, LILACS, and CINAHL electronic databases were searched to identify studies that assessed the impact of telemedicine on clinical outcomes, with no publication date restrictions. The reference lists of the selected articles were hand-searched for additional studies that had not been identified by the initial electronic search. Studies were included if they had a cohort design, used telemedicine, were conducted in PICUs or specialized PICUs, and were published in Portuguese, English, or Spanish. Two groups of reviewers independently screened titles and abstracts for inclusion. The same group of reviewers independently assessed the full-text articles for eligibility and extracted the following information: telecommunication method, intervention characteristics, patient characteristics, sample size, and main results. Studies were meta-analyzed using a random-effects model to estimate the pooled prevalence of PICU mortality and length of PICU stay. Risk of bias was assessed using the Newcastle-Ottawa Scale. Of 2703 studies initially identified, 2226 had their titles and abstracts screened. Of these, 53 were selected for full-text reading, of which 10 were included and analyzed. The main results of interest were length of PICU stay, number of deaths or mortality rate, and satisfaction of health professionals and family members. The results of meta-analysis show that the mortality rate reduced by 34% with an increase of the length of PICU stay in the PICUs with the use of telemedicine. Family members and health professionals were satisfied with the use of telemedicine. Telemedicine has the potential to improve PICU outcomes, such as mortality rate and family and staff satisfaction. However, it extended length of PICU stay in the studies included in this systematic review.
Subject(s)
Telemedicine/methods , Data Management , HumansABSTRACT
Foodborne infections with enterohemorrhagic Escherichia coli (EHEC) are a major cause of diarrheal illness in humans and can lead to severe complications such as hemolytic uremic syndrome. Cattle and other ruminants are the main reservoir of EHEC, which enters the food chain through contaminated meat, dairy, or vegetables. Here, we describe the establishment of a vertebrate model for foodborne EHEC infection, using larval zebrafish (Danio rerio) as a host and the protozoan prey Paramecium caudatum as a vehicle. We follow pathogen release from the vehicle, intestinal colonization, microbe-host interactions, and microbial gene induction within a live vertebrate host, in real time, throughout the course of infection. We demonstrate that foodborne EHEC colonizes the gastrointestinal tract faster and establishes a higher burden than waterborne infection. Expression of the locus of enterocyte effacement (LEE), a key EHEC virulence factor, was observed early during infection, mainly at sites that experience fluid shear, and required tight control to enable successful host colonization. EHEC infection led to strain- and LEE-dependent mortality in the zebrafish host. Despite the presence of the endogenous microbiota limiting EHEC colonization levels, EHEC colonization and virulence can be studied either under gnotobiotic conditions or against the backdrop of an endogenous (and variable) host microbiota. Finally, we show that the model can be used for investigation of factors affecting shedding and transmission of bacteria to naive hosts. Overall, this constitutes a useful model, which ideally complements the strengths of existing EHEC vertebrate models. IMPORTANCE Enterohemorrhagic Escherichia coli (EHEC) is a foodborne pathogen which can cause diarrhea, vomiting, and, in some cases, severe complications such as kidney failure in humans. Up to 30% of cattle are colonized with EHEC, which can enter the food chain through contaminated meat, dairy, and vegetables. In order to control infections and stop transmission, it is important to understand what factors allow EHEC to colonize its hosts, cause virulence, and aid transmission. Since this cannot be systematically studied in humans, it is important to develop animal models of infection and transmission. We developed a model which allows us to study foodborne infection in zebrafish, a vertebrate host that is transparent and genetically tractable. Our results show that foodborne infection is more efficient than waterborne infection and that the locus of enterocyte effacement is a key virulence determinant in the zebrafish model. It is induced early during infection, and loss of tight LEE regulation leads to a decreased bacterial burden and decreased host mortality. Overall, the zebrafish model allows us to study foodborne infection, including pathogen release from the food vehicle and gene regulation and its context of host-microbe interactions, as well as environmental shedding and transmission to naive hosts.
ABSTRACT
BACKGROUND/AIMS: From quantitative trait locus mapping in inbred mice, we identified the Nr1h4 gene encoding the nuclear bile salt receptor FXR as a candidate gene for the cholesterol gallstone susceptibility locus Lith7. Here, we investigated further an association of the gene encoding FXR and gallstone susceptibility in mice and humans. METHODS: The Nr1h4 gene was sequenced in inbred mouse strains with susceptible and resistant Lith7 alleles. Quantitative RT-PCR was employed to determine mRNA expression levels. Gallstone carriers and control subjects of three different populations comprising 1004 individuals were genotyped for polymorphisms of the orthologous human gene detected by sequencing. RESULTS: Expression and sequence analyses in inbred mice were consistent with Nr1h4 underlying Lith7. In the human populations, we identified three frequent haplotypes that accounted for > 95% of all haplotypes observed. In a Mexican population, the most common haplotype NR1H4_1 was associated with gallstone prevalence. In contrast, NR1H4_1 displayed no association with gallstone prevalence in a German population, whereas in a Chilean population we observed a trend towards a protective effect of NR1H4_1. CONCLUSIONS: Our study in an inbred mouse model and in three ethnically distinct populations indicates complex interactions of NR1H4 alleles and other risk factors for the development of cholelithiasis.
