New device for self-assisted breathing exercises in critical adult tracheostomized patients: protocol for a double blind randomized clinical trial
Novo dispositivo para exercício respiratório auto-assistido em pacientes críticos traqueostomizados: protocolo para um ensaio clínico randomizado duplo cego
Deziel de Oliveira Siqueira, Gustavo Moreira de Oliveira, Hiago Vinicius Costa Silva, João Paulo Rodrigues Pacheco, Glória Medeiros Gomes, Adriana Cláudia Lunardi, Elinaldo da Conceição dos Santos
Abstract
Background: Tracheostomized patients have a higher chance of complications and mortality. The Quintero Lung Re-expansion Device (QLRD) was developed with the aim of preventing complications and reducing mortality, however, a clinical trial is needed to test its effectiveness. Aim: To evaluate the effectiveness of the QLRD, compared to incentive spirometry, on clinical outcomes, tracheostomy tube dwell time, length of hospital stay, comfort, and usability of the QLRD in tracheostomized inpatients. Methods: This clinical trial will involve 79 adult inpatients, allocated into two groups: intervention (IG) and control (CG). The IG will undergo daily respiratory exercise using the QLRD, twice a day, performing 2 to 4 sessions of 20 repetitions until the tracheostomy cannula is removed. The number of sessions will increase from 2 in the first four days to 4 after this period. The CG will perform incentive spirometry. The following outcomes; lung aeration (Lung Ultrasound Score), tracheostomy tube dwell time, length of hospital stay, adverse events, complications (bleeding, pneumothorax, subcutaneous emphysema, among others), need for supplemental oxygen support, peripheral oxygen saturation, lung function (spirometry), respiratory muscle strength (manovacuometer), comfort of therapy, return to invasive mechanical ventilation, ORLD usability, and implementation will be evaluated. Jamovi statistical software will be used. Results: The results of the trial will demonstrate whether the QLRD is easy and safe to use, and clinically beneficial. Furthermore, the findings can be used to determine whether the results of this study protocol can be implemented in clinical practice in the future. Conclusion: The QLRD may represent a new effective device for use in the recovery of tracheostomized patients.
Keywords
Resumo
Introdução: Pacientes traqueostomizados têm uma chance maior de mortalidade e complicações. O Dispositivo de Reexpansão Pulmonar Quintero (DRPQ) foi desenvolvido na tentativa de prevenir complicações e reduzir a mortalidade. No entanto, é necessário ensaio clínico para testar a sua efetividade. Objetivo: avaliar a efetividade do DRPQ, em comparação à espirometria de incentivo, em desfechos clínicos, tempo de permanência do tubo de traqueostomia, tempo de internação hospitalar, conforto e usabilidade do DRPQ em pacientes hospitalizados traqueostomizados. Métodos: Este ensaio clínico irá envolver 68 pacientes adultos, alocados em dois grupos: intervenção (GI) e controle (GC). O GI será submetido a exercícios respiratórios com DRPQ diariamente, duas vezes ao dia, realizando 20 repetições em 2 a 4 sessões até a remoção da canulação da traqueostomia. As sessões aumentarão de 2 para 4, após os quatro primeiros dias de intervenção. O GC usará incentivador respiratório. Os desfechos aeração pulmonar (Ultrassom Pulmonar), tempo de permanência do tubo de traqueostomia, tempo de internação hospitalar, eventos adversos, complicações (sangramento, pneumotórax, enfisema subcutâneo, entre outros), necessidade de suporte de oxigênio suplementar, saturação periférica de oxigênio, função pulmonar (espirometria), força muscular respiratória (manovacuometria), conforto da terapia, retorno para ventilação mecânica invasiva, usabilidade do DRPQ, e implementação serão avaliados. O software estatístico Jamovi será usado. Resultados: será possível descobrir se o DRPQ é ou não fácil de usar, seguro e clinicamente benéfico. E, ainda, se os resultados deste estudo podem ser implementados na prática clínica no futuro. Conclusão: futuramente, podemos encontrar ou não um novo dispositivo efetivo para ser usado na recuperação dos pacientes traqueostomizados.
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Referências
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Submetido em:
02/01/2025
Aceito em:
19/02/2026
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