Efeito de cateteres intravenosos periféricos longos na manutenção dos acessos vasculares até o término da indicação clínica: revisão de escopo e protocolo de ensaio clínico randômico
Data
2024-04-08
Autores
Pereira, Maria Luiza Silva 
Orientadores
Pedreira, Mavilde da Luz Gonçalves
Tipo
Dissertação de mestrado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: Cateteres intravenosos periféricos (CIPs) são dispositivos de amplo uso clínico, disponíveis em variados modelos e características. Um dos avanços tecnológicos dos CIPs advém da premissa de promover cateterização de trajeto mais longo e, possivelmente, mais profundo de veias periféricas, acarretando o desenvolvimento de cateteres intravenosos periféricos longos (CIPLs). Objetivos: Identificar e apresentar as informações disponíveis sobre os CIPLs quanto ao tempo de permanência e ocorrência de eventos adversos em pacientes adultos. Elaborar um protocolo de Estudo clínico Randômico (ECR) para verificar o efeito de CIPLs na manutenção do acesso vascular até o término da indicação clínica em pacientes adultos. Métodos: Delineou-se revisão de escopo fundamentada nas diretrizes do Joana Briggs Institute (JBI) e registrada no Open Science Framework (OSF). As referências extraídas das bases de dados foram gerenciadas no software Zotero, com remoção de duplicatas, e posteriormente no Rayyan CQRI Systems®, sendo analisadas de modo independente por dois revisores. A análise dos dados incluiu variáveis relacionadas ao paciente, cateteres e cuidados de inserção, manutenção e remoção dos CIPLs. Para alcance do segundo objetivo apresenta-se o protocolo de ECR e de superioridade, cego para a análise da variável dependente e estatística de dados, de centro único, realizado em hospital de grande porte da cidade de Salvador, na Bahia. Para a composição da amostra delimitou-se estudo de pacientes maiores de 18 anos, com indicação de terapia intravenosa por via periférica ≥96 horas. Frente ao atendimento de critérios de inclusão, a randomização resultará na formação de grupos paralelos de estudo, denominados grupo intervenção, submetido à inserção de CIPL, e grupo controle, que receberá CIPs curtos (CIPCs). Variáveis dependentes, independentes e complementares foram incluídas no protocolo. Frente à hipótese de estudo de que “a retirada do CIP por término de indicação clínica é maior em pacientes adultos submetidos a cateterização com CPILs do que CIPCs”, as análises inferenciais fixam em 5% o nível de rejeição da hipótese de nulidade. Resultados: A revisão de escopo incluiu 13 artigos, publicados entre 2012 e 2023, abrangendo 8600 pacientes. Identificaram-se estudos observacionais e descritivos (84,6%) e ECRs (15,4%). Predominou uso de CIPLs de 8 cm (53,8%), 20 G (53,8%), inserção por ultrassonografia (100,0%) e técnica de Seldinger (61,5%), com tempo de permanência de 8,94 dias (4,6-14,7 dias), e os principais motivos de retirada precoce foram flebite e obstrução. O protocolo do ECR é apresentado conforme as normas do Consolidated Standards of Reporting Trials (CONSORT). O cálculo amostral considerou 5% de significância e poder do teste de 80% da variável independente sobre a dependente, com base nos resultados de ECR identificado na revisão, estimando-se 604 pacientes. A variável dependente refere-se à retirada do CIP por término da indicação clínica. O protocolo do ECR abrange estudo de 26 variáveis, sendo cinco (19,2%) de caracterização demográfica e clínica, 11 (42,3%) da terapia intravenosa e cateter, e 10 (38,5%) de eventos adversos, além das variáveis independente e dependente. Foram elaborados os procedimentos de inserção, manutenção e retirada de CIPLs e CIPCs, bem como delineadas estratégias de implementação, seguimento e de garantia de adesão ao protocolo do estudo. Conclusão: Identifica-se inicial produção e carência de robustas evidências científicas que demonstrem a influência de CIPLs na promoção de eficácia e segurança, com dados que indicam possíveis melhores benefícios para pacientes com acesso venoso difícil. Foi iniciada a inclusão do protocolo do ensaio clínico na plataforma Clinical Trials e no Registro Brasileiro de Ensaios Clínicos (ReBEC), não se identificando realização de pesquisas similares em nosso país, ressaltando o potencial para contribuir com evidências que permitam avanço do conhecimento para o alcance do resultado clínico esperado de permanência dos CIPs até o término do tratamento, e sem eventos adversos.
Introduction: Peripheral intravenous catheters (PICV) are devices widely used in clinical practice, available in several types and characteristics. One of the technological advances of PIVCs is the premise of promoting catheterization of a longer path and, possibly, deeper peripheral veins, resulting in the development of long peripheral intravenous catheters (LPIVCs). Objectives: To identify and present the available information on LPIVCs regarding length of stay and occurrence of adverse events in adult patients. Develop a Randomized Clinical Study (RCT) protocol to verify the effect of LPIVCs on the maintenance of vascular access until the end of the clinical indication in adult patients. Methods: A scoping review based on the guidelines of Joana Briggs Institute (JBI) and registered in the Open Science Framework (OSF) was designed. The references extracted from the databases were managed in the Zotero software, with removal of duplicates, and in Rayyan CQRI Systems®, being analysed independently by two reviewers. Data analysis included variables related to the patient, catheter, and care for insertion, maintenance, and removal. To achieve the second objective the protocol of a superiority, a RCT was designed, blinded to the analysis of the dependent variable and statistical data, of a single centre, carried out in a large hospital in the city of Salvador, Bahia. The sample consisted of patients over 18 years of age, with indication of peripheral intravenous therapy for ≥96 hours. In view of the fulfilment of the inclusion criteria, randomization will result in the formation of parallel study groups, called intervention groups, submitted to the insertion of LPIVC, and control group, submitted to the conventional procedure of short peripheral intravenous catheter (SPIVC). Dependent, independent and complementary variables were included in the protocol. In view of the study hypothesis that "the withdrawal of the PIVC due to the end of clinical indication is higher in adult patients undergoing catheterization with LPIVCs than SPIVCs", the inferential analyses set the level of rejection of the null hypothesis at 5%. Results: The scoping review included 13 articles, published between 2012 and 2023, covering 8600 patients. Observational and descriptive studies (84.6%) and RCTs (15.4%) were identified. There was a predominance of LPIVCs of 8 cm (53.8%), 20G (53.8%), inserted by ultrasound (100.0%) and Seldinger technique (61.5%), with a length of stay of 8.94 days (4.6-14.7 days), and the main failure causes were phlebitis and obstruction. The RCT protocol is presented according to the standards of the Consolidated Standards of Reporting Trials (CONSORT). The sample size calculation considered 5% significance and the power of the test of 80% of the independent variable over the dependent variable, based on the results of one RCT identified in the review, estimating 604 patients, 302 allocated to each study group. The dependent variable refers to the withdrawal of the PIVC at the end of the clinical indication. The RCT protocol encompasses a study of 26 variables, of which five (19.2%) were demographic and clinical, eleven (42.3%) related to intravenous therapy and catheter, and ten (38.5%) embracing adverse events. in addition to the independent and dependent variables. The procedures for insertion, maintenance, and withdrawal of LPIVCs and SPIVCs were elaborated for implementation and follow-up, as well as strategies to ensure adherence to the study protocol. Conclusion: The data demonstrated an initial production and lack of robust scientific evidence describing the influence of LPIVCs in promoting efficacy and safety in intravenous therapy, indicating possible major benefits for patients with difficult venous access. The clinical trial protocol inclusion in the platforms Clinical Trials and Brazilian Registry of Clinical Trials (ReBEC) was initiated, and no similar studies were identified in our country, with the potential to contribute with evidence that allows the advancement of scientific knowledge to achieve the expected clinical outcome of dwell time of the PIVCs until the end of the treatment and without complications.
Introduction: Peripheral intravenous catheters (PICV) are devices widely used in clinical practice, available in several types and characteristics. One of the technological advances of PIVCs is the premise of promoting catheterization of a longer path and, possibly, deeper peripheral veins, resulting in the development of long peripheral intravenous catheters (LPIVCs). Objectives: To identify and present the available information on LPIVCs regarding length of stay and occurrence of adverse events in adult patients. Develop a Randomized Clinical Study (RCT) protocol to verify the effect of LPIVCs on the maintenance of vascular access until the end of the clinical indication in adult patients. Methods: A scoping review based on the guidelines of Joana Briggs Institute (JBI) and registered in the Open Science Framework (OSF) was designed. The references extracted from the databases were managed in the Zotero software, with removal of duplicates, and in Rayyan CQRI Systems®, being analysed independently by two reviewers. Data analysis included variables related to the patient, catheter, and care for insertion, maintenance, and removal. To achieve the second objective the protocol of a superiority, a RCT was designed, blinded to the analysis of the dependent variable and statistical data, of a single centre, carried out in a large hospital in the city of Salvador, Bahia. The sample consisted of patients over 18 years of age, with indication of peripheral intravenous therapy for ≥96 hours. In view of the fulfilment of the inclusion criteria, randomization will result in the formation of parallel study groups, called intervention groups, submitted to the insertion of LPIVC, and control group, submitted to the conventional procedure of short peripheral intravenous catheter (SPIVC). Dependent, independent and complementary variables were included in the protocol. In view of the study hypothesis that "the withdrawal of the PIVC due to the end of clinical indication is higher in adult patients undergoing catheterization with LPIVCs than SPIVCs", the inferential analyses set the level of rejection of the null hypothesis at 5%. Results: The scoping review included 13 articles, published between 2012 and 2023, covering 8600 patients. Observational and descriptive studies (84.6%) and RCTs (15.4%) were identified. There was a predominance of LPIVCs of 8 cm (53.8%), 20G (53.8%), inserted by ultrasound (100.0%) and Seldinger technique (61.5%), with a length of stay of 8.94 days (4.6-14.7 days), and the main failure causes were phlebitis and obstruction. The RCT protocol is presented according to the standards of the Consolidated Standards of Reporting Trials (CONSORT). The sample size calculation considered 5% significance and the power of the test of 80% of the independent variable over the dependent variable, based on the results of one RCT identified in the review, estimating 604 patients, 302 allocated to each study group. The dependent variable refers to the withdrawal of the PIVC at the end of the clinical indication. The RCT protocol encompasses a study of 26 variables, of which five (19.2%) were demographic and clinical, eleven (42.3%) related to intravenous therapy and catheter, and ten (38.5%) embracing adverse events. in addition to the independent and dependent variables. The procedures for insertion, maintenance, and withdrawal of LPIVCs and SPIVCs were elaborated for implementation and follow-up, as well as strategies to ensure adherence to the study protocol. Conclusion: The data demonstrated an initial production and lack of robust scientific evidence describing the influence of LPIVCs in promoting efficacy and safety in intravenous therapy, indicating possible major benefits for patients with difficult venous access. The clinical trial protocol inclusion in the platforms Clinical Trials and Brazilian Registry of Clinical Trials (ReBEC) was initiated, and no similar studies were identified in our country, with the potential to contribute with evidence that allows the advancement of scientific knowledge to achieve the expected clinical outcome of dwell time of the PIVCs until the end of the treatment and without complications.
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Citação
PEREIRA, Maria Luiza Silva. Efeito de cateteres intravenosos periféricos longos na manutenção dos acessos vasculares até o término da indicação clínica: revisão de escopo e protocolo de ensaio clínico randômico. 2024. 124 f. Dissertação (Mestrado em Enfermagem) - Escola Paulista de Enfermagem, Universidade Federal de São Paulo (UNIFESP), São Paulo, 2024.