Estudo clínico, randômico e controlado sobre o efeito da transiluminação no sucesso da cateterização intravenosa periférica em crianças
Data
2021-10-01
Autores
Santos, Luciano Marques dos 
Orientadores
Avelar, Ariane Ferreira Machado
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: A cateterização intravenosa periférica (CIP) é frequentemente realizada em crianças hospitalizadas, sendo um desafio para os profissionais de enfermagem alcançar o sucesso deste procedimento na primeira tentativa. As diversas tentativas de cateterização ocasionam estresse, dor, sofrimento, ansiedade e depleção da vasculatura periférica. Por isso, a transiluminação da pele poderá melhorar a visibilidade da veia e posibilitar o sucesso da CIP, contribuindo com melhores desfechos clínicos e assistenciais. Objetivos: Comparar o efeito da transiluminação no sucesso da CIP em crianças hospitalizadas em relação ao método clínico tradicional; analisar se a visibilidade da veia na primeira tentativa de CIP é modificada com o uso da transiluminação, comparada ao método clínico tradicional; identificar o número de tentativas de cateterização até a obtenção do acesso, segundo transiluminação e método clínico tradicional e verificar se o uso da transiluminação reduz o tempo para visualizar, selecionar, cateterizar a veia e obter o acesso intravenoso em crianças hospitalizadas. Método: Trata-se de um ensaio clínico, randômico, controlado, paralelo e aberto, realizado em um hospital pediátrico privado de Feira de Santana, Bahia, Brasil, entre junho de 2020 e junho de 2021, após aprovação do mérito ético (3.234.517) e registrado no Registro Brasileiro de Ensaios Clínicos (RBR-838r987). Para a operacionalização do ensaio clínico, uma equipe de cuidados clínicos em terapia intravenosa foi qualificada para a aplicação dos protocolos e tecnologias relativas a CIP por meio de onze estações teóricas e sete práticas. A partir do cálculo amostral foram recrutadas para o ensaio clínico 310 crianças, 155 alocadas aleatoriamente no grupo intervenção (cateterização realizada com a transiluminação da pele com o Venoscópio IV Plus®) e 155 no grupo controle (cateterização pelo método clínico tradicional). Foram calculados os riscos relativos e seus respectivos intervalos de confiança de 95%, empregando-se o teste Qui-quadrado, Exato de Fischer ou Teste T de Student, nível de significancia de 5%. Curvas de sobrevida foram calculadas pelo método de Kaplan-Meier e estimadas diferenças com os testes de Log-rank, Breslow e Tarone-Ware rank, com nível de significância de 5%. Resultados: Os grupos foram homogêneos em relação à maioria das características investigadas, exceto nas variáveis sexo (p=0,022), dominância lateral (p=0,006), preparo das crianças até 12 meses de idade para a CIP (p=0,026), formato da veia na primeira tentativa (p<0,001) e intervalo entre a punção venosa anterior para coleta de sangue e a cateterização atual (p=0,048). As veias foram mais visíveis com a transiluminação (p<0,01; Risco Relativo=1,17; IC95%=1,10-1,25). No entanto, a média de número de tentativas não diferiu entre os grupos (p=1,000). No grupo intervenção o percentual de sucesso da CIP foi de 69,7% e no grupo controle 71%, mas sem diferença estatística significante (p=0,804; Risco Relativo=0,98; IC95%=0,85-1,13). A média de tempo para visualizar e selecionar a veia (p<0,001) e para a obtenção do acesso intravenoso na primeira tentativa de cateterização (p=0,002), assim como do tempo global destas intervenções com o Venoscópio IV Plus® foi menor em comparação às do grupo controle. As curvas de sobrevivência dos dois grupos foram significativamente diferentes entre si. Conclusão: O percentual de sucesso da CIP não sofreu efeito da transiluminação comparado ao método clínico tradicional, porém a intervenção testada reduziu o tempo de visualização e seleção da veia e de obtenção do acesso intravenoso na primeira tentativa de cateterização, assim como o tempo total destas ações.
Introduction: Peripheral intravenous catheterization (PIC) is frequently performed in hospitalized children, being a challenge for nursing professionals to achieve the success of this procedure in the first attempt. Several catheterization attempts cause stress, pain, suffering, anxiety and depletion of the peripheral vasculature. Therefore, the transillumination of the skin can improve the visibility of the vein and enable the success of the CIP, contributing to better clinical and care outcomes. Objectives: To compare the effect of transillumination on the success of PIC in hospitalized children in relation to the traditional clinical method; to analyze whether the visibility of the vein in the first PIC attempt is modified with the use of transillumination, compared to the traditional clinical method; identify the number of catheterization attempts until access is obtained, according to transillumination and traditional clinical method, and verify whether the use of transillumination reduces the time to visualize, select, catheterize the vein and obtain intravenous access in hospitalized children. Method: This is a clinical, randomized, controlled, parallel and open trial, carried out in a private pediatric hospital in Feira de Santana, Bahia, Brazil, between June 2020 and June 2021, after approval of ethical merit (3,234. 517) and registered in the Brazilian Registry of Clinical Trials (RBR-838r987). For the operationalization of the clinical trial, a clinical care team in intravenous therapy was qualified for the application of protocols and technologies related to CIP through eleven theoretical and seven practical stations. From the sample calculation, 310 children were recruited for the clinical trial, 155 randomly allocated to the intervention group (catheterization performed with a Venoscope IV Plus®) and 155 to the control group (catheterization using the traditional clinical method). Relative risks and their respective 95% confidence intervals were calculated using the Chi-square test, Fisher's exact test or Student's t test, 5% significance level. Survival curves were calculated using the Kaplan-Meier method and differences were estimated using the Log-rank, Breslow and Tarone-Ware rank tests, with a significance level of 5%. Results: The groups were homogeneous in relation to most of the investigated characteristics, except for the variables gender (p=0.022), lateral dominance (p=0.006), preparation of children up to 12 months of age for CIP (p=0.026), format of the vein in the first attempt (p<0.001) and interval between the previous venipuncture for blood collection and the current catheterization (p=0.048). The veins were more visible with transillumination (p<0.01; Relative Risk=1.17; 95%CI=1.10-1.25). However, the mean number of attempts did not differ between groups (p=1,000). In the intervention group the percentage of success of the CIP was 69.7% and in the control group 71%, but without statistically significant difference (p=0.804; Relative Risk=0.98; 95%CI=0.85-1.13). The mean time to view and select the vein (p<0.001) and to obtain the intravenous access in the first catheterization attempt (p=0.002), as well as the overall time of these interventions with the Venoscope IV Plus®, was lower compared to those of the control group. The survival curves of the two groups were significantly different from each other. Conclusion: The percentage of success of the CIP did not suffer the effect of transillumination compared to the traditional clinical method. The method reduced the time for visualization and selection of the vein and for obtaining intravenous access in the first catheterization attempt, as well as the total time of these interventions.
Introduction: Peripheral intravenous catheterization (PIC) is frequently performed in hospitalized children, being a challenge for nursing professionals to achieve the success of this procedure in the first attempt. Several catheterization attempts cause stress, pain, suffering, anxiety and depletion of the peripheral vasculature. Therefore, the transillumination of the skin can improve the visibility of the vein and enable the success of the CIP, contributing to better clinical and care outcomes. Objectives: To compare the effect of transillumination on the success of PIC in hospitalized children in relation to the traditional clinical method; to analyze whether the visibility of the vein in the first PIC attempt is modified with the use of transillumination, compared to the traditional clinical method; identify the number of catheterization attempts until access is obtained, according to transillumination and traditional clinical method, and verify whether the use of transillumination reduces the time to visualize, select, catheterize the vein and obtain intravenous access in hospitalized children. Method: This is a clinical, randomized, controlled, parallel and open trial, carried out in a private pediatric hospital in Feira de Santana, Bahia, Brazil, between June 2020 and June 2021, after approval of ethical merit (3,234. 517) and registered in the Brazilian Registry of Clinical Trials (RBR-838r987). For the operationalization of the clinical trial, a clinical care team in intravenous therapy was qualified for the application of protocols and technologies related to CIP through eleven theoretical and seven practical stations. From the sample calculation, 310 children were recruited for the clinical trial, 155 randomly allocated to the intervention group (catheterization performed with a Venoscope IV Plus®) and 155 to the control group (catheterization using the traditional clinical method). Relative risks and their respective 95% confidence intervals were calculated using the Chi-square test, Fisher's exact test or Student's t test, 5% significance level. Survival curves were calculated using the Kaplan-Meier method and differences were estimated using the Log-rank, Breslow and Tarone-Ware rank tests, with a significance level of 5%. Results: The groups were homogeneous in relation to most of the investigated characteristics, except for the variables gender (p=0.022), lateral dominance (p=0.006), preparation of children up to 12 months of age for CIP (p=0.026), format of the vein in the first attempt (p<0.001) and interval between the previous venipuncture for blood collection and the current catheterization (p=0.048). The veins were more visible with transillumination (p<0.01; Relative Risk=1.17; 95%CI=1.10-1.25). However, the mean number of attempts did not differ between groups (p=1,000). In the intervention group the percentage of success of the CIP was 69.7% and in the control group 71%, but without statistically significant difference (p=0.804; Relative Risk=0.98; 95%CI=0.85-1.13). The mean time to view and select the vein (p<0.001) and to obtain the intravenous access in the first catheterization attempt (p=0.002), as well as the overall time of these interventions with the Venoscope IV Plus®, was lower compared to those of the control group. The survival curves of the two groups were significantly different from each other. Conclusion: The percentage of success of the CIP did not suffer the effect of transillumination compared to the traditional clinical method. The method reduced the time for visualization and selection of the vein and for obtaining intravenous access in the first catheterization attempt, as well as the total time of these interventions.
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Citação
SANTOS, L. M. dos. Estudo clínico, randômico e controlado sobre o efeito da transiluminação no sucesso da cateterização intravenosa periférica em crianças. São Paulo, 2021. 255 f. Tese (Doutorado em Enfermagem) – Escola Paulista de Enfermagem (EPE), Universidade Federal de São Paulo (UNIFESP). São Paulo, 2021.