Konkayev Aidos, Bekniyazova Assema
Department of Anesthesiology and Intensive Care, Astana Medical University, Astana, Kazakhstan.
The National Scientific Center of Traumatology and Orthopedics Named After Academician Batpenov N.D., Astana, Kazakhstan.
Front Med (Lausanne). 2023 Dec 14;10:1225384. doi: 10.3389/fmed.2023.1225384. eCollection 2023.
Coronavirus infection is a dangerous airborne disease that can lead to serious lung damage. Data on the effectiveness of low-frequency chest vibrations in the treatment of lung diseases are available; however, not so many of them exist. Vibroacoustic pulmonary therapy is a component of physiotherapy that improves lung perfusion and drainage without requiring active patient participation. This study aimed to increase statistical efficiency through maximizing the relevant information obtained from the clinical data. Calculating the sample size to determine the power of subsequent studies was also necessary.
A pilot randomized parallel trial involving 60 patients was conducted. The patients were divided into two equal groups, where they received sessions of vibroacoustic pulmonary therapy using the "VibroLung" device in two modes "acute respiratory distress syndrome (ARDS)" and "Pneumonia," with identical treatment. The patients were > 18 years old with detected COVID-19 by PCR and grade 2 and 3 lung lesions detected by computer tomography (CT). Blood sampling was performed in the morning at the same time before and after the hardware massage to determine PaO, PaCO, and P/F.
As a result of the test, the following data were obtained: on the first day in the group using the "ARDS" mode, PaO indicators averaged 65, CI 95% [58.6-73.2] and on average 77.5, CI 95% [69.8-85.2], "before" and "after," respectively, which indicates improved oxygenation after the procedure. However, in the second group with the "Pneumonia" mode after its use, PaCO was higher after the session, on average 48.7, CI 95% [40.8-56.6], whereas before that, the following indicators had, on average 43.6, CI 95% [37.2-50].
Thus, the data obtained yielded ambiguous results, which are the basis for further study in future randomized controlled trials. As the treatment of coronavirus infection has no etiological treatment, even small shifts in the therapy of this category of patients can be significant.
ClinicalTrials.gov, identifier NCT05143372.
冠状病毒感染是一种危险的空气传播疾病，可导致严重的肺部损伤。关于低频胸部振动治疗肺部疾病有效性的数据是可用的；然而，这类数据并不多。振动声学肺部治疗是物理治疗的一个组成部分，可改善肺部灌注和引流，且无需患者主动参与。本研究旨在通过最大化从临床数据中获得的相关信息来提高统计效率。计算样本量以确定后续研究的效能也是必要的。
进行了一项涉及60名患者的初步随机平行试验。患者被分为两组，每组人数相等，他们使用“VibroLung”设备以“急性呼吸窘迫综合征（ARDS）”和“肺炎”两种模式接受振动声学肺部治疗，治疗方式相同。患者年龄大于18岁，经PCR检测确诊为COVID-19，且经计算机断层扫描（CT）检测出2级和3级肺部病变。在硬件按摩前后的同一时间采集血液样本，以测定动脉血氧分压（PaO）、动脉血二氧化碳分压（PaCO）和氧合指数（P/F）。
试验结果如下：在使用“ARDS”模式的组中，第一天的PaO指标平均值在“治疗前”为65，95%置信区间[58.6 - 73.2]，在“治疗后”平均为77.5，95%置信区间[69.8 - 85.2]，这表明治疗后氧合情况有所改善。然而，在使用“肺炎”模式的第二组中，治疗后PaCO升高，平均为48.7，95%置信区间[40.8 - 56.6]，而在此之前，平均指标为43.6，95%置信区间[37.2 - 50]。
因此，所获得的数据产生了不明确的结果，这是未来随机对照试验进一步研究的基础。由于冠状病毒感染没有病因治疗方法，即使这类患者治疗上的微小变化也可能具有重要意义。
ClinicalTrials.gov，标识符NCT05143372。
