Ensaio clínico randomizado de avaliação da efetividade da inspiração profunda sustentada na prevenção de complicações pulmonares pós-operatórias e das respostas hormonal e imunológica em doentes submetidos à cirurgia no andar superior do abdome
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Arquivos
Data
2007
Autores
Silva, Elida Mara Carneiro da [UNIFESP]
Orientadores
Matos, Delcio [UNIFESP]
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
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OBJETIVO: Avaliar os efeitos da inspiração profunda sustentada na prevenção de
complicações pulmonares pós-operatórias e nas respostas hormonais e imunológicas em pacientes submetidos à cirurgia no andar superior do abdome. MÉTODOS: O estudo desenhado foi ensaio clínico randomizado. 75 doentes foram incluídos no estudo, sendo 39 alocados, aleatoriamente, no grupo controle que não realizaram nenhuma intervenção e 36, no grupo experimental que realizaram inspiração profunda sustentada em 5 segundos, 3 séries de 10 repetições, uma vez ao dia. As medidas de desfecho primário analisadas foram: exame radiológico do tórax, dosagens sanguíneas do ACTH, cortisol, interleucina-4, interleucina-10 e fator de necrose tumoral, no pré-operatório e 24 e 48 h no pós-operatório e de desfecho secundário foram: exame radiológico do tórax, volume expiratório forçado no primeiro segundo, fluxo expiratório forçado 25-75%, capacidade vital forçada, pressão parcial de oxigênio e pressão parcial de dióxido de carbono, no pré-operatório e 48 h no pós-operatório. O tamanho da amostra foi calculado de 72, sendo 36 para cada grupo em estudo. Os pacientes foram randomizados por processo de envelopes
selados e opacos e sorteados de forma consecutiva. Foram utilizados os testes nãoparamétricos e T de Student conforme a distribuição das variáveis de Kolmogorov e Bartlett para a análise de normalidade e homogeneidade, respectivamente. Nos
dados onde houve pareamento das amostras, usou-se o teste Mann-Whitney. A análise dos testes de qui-quadrado e exato de Fisher foram aplicados para o estudo das associações. O nível de significância adotado foi de p=0,05. RESULTADOS: O tempo de internação foi de 7,2 ± 1,3 dias e 5,7 ± 0,5 dias, entre os grupos controle e experimental. As alterações radiológicas foram observadas em dois doentes (5,6%) do grupo experimental e em seis (15,4%) do grupo controle. Nos doentes do grupo que realizaram válvula anti-refluxo associada à colecistectomia não foram detectadas alterações radiológicas, enquanto houve 3 casos (12,5%) no grupo submetido à cardiomiotomia extramucosa e 5 casos (55,5%) no grupo submetido à esofagectomia (p<0,001). As medianas da concentração plasmática de cortisol nos doentes dos grupos experimental e controle foram 12,8 mcg/dl (4,6-50) e 10,48 mcg/dl (1-29,1), respectivamente, antes da intervenção cirúrgica (p=0,414) e o grupo experimental apresentou aumento dos níveis de cortisol de 12,8 mcg/dl (4,5 – 50) para 23,6 mcg/dl (9,3 – 45,8) após vinte e quatro horas de procedimento cirúrgico (p = 0,049). Quanto às medianas de desfechos da interleucina-4, interleucina-10, ACTH, fator de necrose tumoral alfa, volume expiratório forçado no primeiro segundo, fluxo expiratório forçado 25-75%, capacidade vital forçada, pressão parcial de oxigênio e pressão parcial de dióxido de carbono não foram observadas diferenças estatisticamente
significantes entre os grupos controle e experimental. CONCLUSÃO: O presente estudo conclui que a inspiração profunda sustentada em pacientes submetidos à cirurgia no andar superior do abdome determinou alterações do cortisol plasmático sem, no entanto, influenciar de maneira significativa as complicações pulmonares pós-operatórias e as respostas endócrina e imunológica.
OBJETIVE: To evaluate the effects of the deep sustained inspiration in theprevention of post-surgical pulmonary complications and the hormonal and immunological response in patients submitted to upper abdominal surgeries. METHODS: 75 patients were included in this study; by randomization, 39 were located in the control group and 36 in the experimental group. The main outcome measures analyzed were Chest Radiography, plasma dosage of cortisol, adrenocorticotropic hormone, interleukin-4, interleukin-10 and Tumor Necrosis Factor-alfa, at the pre-surgery and 24 and 48 hour after the surgery, and the forced expiratory volume in one second, forced expiratory flow, forced vital capacity, partial oxygen pressure, and carbon dioxide partial pressure at the pre-surgery and 48 hour after the surgery. The sample size was calculated as 72 patients; assembling 36 cases for each study group. The patients were randomly assigned by drawing sealed dark envelopes consecutively. Non-parametric and Student’s T tests were utilized according with the distribution of the variables of Kolmogorov and Bartlett, for analysis of normality and homogeneity, respectively. In the data with pairing samples, the Mann Whitney test was used. The analysis with Chi-Square and Fisher’s Tests were applied for the study of the associations. The level of significance applied was p= 0,005. RESULTS The inpatient time was 7,2 ± 1,3 days and 5,7 ± 0,5 days, between the experimental and control group. Radiological alterations were observed in 2 (5,6%) patients from the experimental group and in 6 (15,4%) individuals from the control group. Patients who underwent an anti-reflux valve associated with cholecystectomy did not show radiological alterations, whereas, 3 (12,5%) cases were found from the group submitted to extra mucosal cardiotomy and 5 (55,5%) from the group submitted to esophagectomy ( p<0,001). The median of the plasma cortisol levels in the patients from the experimental and control groups were 12,8 mcg/dl (4,6-50) and 10,48 (1-29,1), respectively, before the surgery (p=0,414) and the experimental group showed and increase at the cortisol levels from 12,8 mcg/dl (4,5 – 50) to 23,6 mcg/dl (9,3 – 45,8) after twenty four hours from the surgery. In relation to the median of the outcomes of interleukin-4, interleukin-10 and adrenocorticotropic hormone, TNF-alfa, forced expiratory volume in one second, forced expiratory flow, forced vital capacity, partial oxygen pressure, and carbon dioxide partial pressure in the pre surgery and 48 hour after the surgery were not observed statistical significance between the experimental and the control group. CONCLUSION: This study concluded that the sustained deep inspiration in patients submitted to upper abdominal surgery establishes alterations in the plasma cortisol levels, without influencing significant post-surgical pulmonary complications, or alterations at the endocrinal or immunological response.
OBJETIVE: To evaluate the effects of the deep sustained inspiration in theprevention of post-surgical pulmonary complications and the hormonal and immunological response in patients submitted to upper abdominal surgeries. METHODS: 75 patients were included in this study; by randomization, 39 were located in the control group and 36 in the experimental group. The main outcome measures analyzed were Chest Radiography, plasma dosage of cortisol, adrenocorticotropic hormone, interleukin-4, interleukin-10 and Tumor Necrosis Factor-alfa, at the pre-surgery and 24 and 48 hour after the surgery, and the forced expiratory volume in one second, forced expiratory flow, forced vital capacity, partial oxygen pressure, and carbon dioxide partial pressure at the pre-surgery and 48 hour after the surgery. The sample size was calculated as 72 patients; assembling 36 cases for each study group. The patients were randomly assigned by drawing sealed dark envelopes consecutively. Non-parametric and Student’s T tests were utilized according with the distribution of the variables of Kolmogorov and Bartlett, for analysis of normality and homogeneity, respectively. In the data with pairing samples, the Mann Whitney test was used. The analysis with Chi-Square and Fisher’s Tests were applied for the study of the associations. The level of significance applied was p= 0,005. RESULTS The inpatient time was 7,2 ± 1,3 days and 5,7 ± 0,5 days, between the experimental and control group. Radiological alterations were observed in 2 (5,6%) patients from the experimental group and in 6 (15,4%) individuals from the control group. Patients who underwent an anti-reflux valve associated with cholecystectomy did not show radiological alterations, whereas, 3 (12,5%) cases were found from the group submitted to extra mucosal cardiotomy and 5 (55,5%) from the group submitted to esophagectomy ( p<0,001). The median of the plasma cortisol levels in the patients from the experimental and control groups were 12,8 mcg/dl (4,6-50) and 10,48 (1-29,1), respectively, before the surgery (p=0,414) and the experimental group showed and increase at the cortisol levels from 12,8 mcg/dl (4,5 – 50) to 23,6 mcg/dl (9,3 – 45,8) after twenty four hours from the surgery. In relation to the median of the outcomes of interleukin-4, interleukin-10 and adrenocorticotropic hormone, TNF-alfa, forced expiratory volume in one second, forced expiratory flow, forced vital capacity, partial oxygen pressure, and carbon dioxide partial pressure in the pre surgery and 48 hour after the surgery were not observed statistical significance between the experimental and the control group. CONCLUSION: This study concluded that the sustained deep inspiration in patients submitted to upper abdominal surgery establishes alterations in the plasma cortisol levels, without influencing significant post-surgical pulmonary complications, or alterations at the endocrinal or immunological response.
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Citação
CARNEIRO, Elida Mara. Ensaio clínico randomizado de avaliação da efetividade da inspiração profunda sustentada na prevenção de complicações pulmonares pós-operatórias e das respostas hormonal e imunológica em doentes submetidos à cirurgia no andar superior do abdome. 2007. 106 f. Tese (Doutorado em Ciências) – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2007.