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吸气肌训练对预防有长期住院风险患者不良结局的安全性和有效性。

Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation.

作者信息

Nepomuceno Balbino Rivail Ventura, Barreto Mayana de Sá, Almeida Naniane Cidreira, Guerreiro Caroline Ferreira, Xavier-Souza Eveline, Neto Mansueto Gomes

机构信息

Medicine and Health, Federal University of Bahia - UFBA, Av. Tancredo Neves, n 1283, Sala 902 - Edf. Ômega - Caminho das Árvores, Salvador, Bahia, ZIP 41820-021, Brazil.

Department of Biofunção, Institute of Health Sciences - ICS, UFBA, Av. Tancredo Neves, n 1283, Sala 902 - Edf. Ômega - Caminho das Árvores, Salvador, Bahia, ZIP 41820-021, Brazil.

出版信息

Trials. 2017 Dec 28;18(1):626. doi: 10.1186/s13063-017-2372-y.

Abstract

BACKGROUND

The early institution of inspiratory muscle training on hospitalised patients with no established respiratory deficits could prevent in-hospital adverse outcomes that are directly or indirectly associated to the loss of respiratory muscle mass inherent to a prolonged hospital stay. The objective of the clinical trial is to assess the impact of inspiratory muscle training on hospital inpatient complications.

METHODS

This is a double-blind randomised controlled trial. Subjects in the intervention group underwent an inspiratory muscle training loaded with 50% maximum inspiratory pressure twice daily for 4 weeks from study enrolment. Patients were randomly assigned to an inspiratory muscle training group or a sham inspiratory muscle training group. All patients received conventional physiotherapy interventions. Baseline and post-intervention respiratory and peripheral muscle strength, functionality (performance of activities of daily living), length of hospital stay, and death were evaluated. Clinical outcomes were assessed until hospital discharge. This study was approved by the Institutional Hospital Ethics Committee (03/2014).

RESULTS

Thirty-one patients assigned to the inspiratory muscle training group and 34 to the sham inspiratory muscle training group were analysed. Patients in the inspiratory muscle training group had a shorter mean length of hospital stay (35.3 ± 2.7 vs. 41.8 ± 3.5 days, p < 0.01) and a lower risk of endotracheal intubation (relative risk (RR) = 0.36; 95% confidence interval (CI) 0.27-0.97; p = 0.03) as well as muscle weakness (RR = 0.36; 95% CI 0.19-0.98; p = 0.02) and mortality (RR = 0.23; 95% CI 0.2-0.94; p = 0.04). The risk of adverse events did not differ significantly between groups.

CONCLUSION

Inspiratory muscle training was a protective factor against endotracheal intubation, muscle weakness, and mortality.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT02459444 . Registered on 19 May 2015.

摘要

背景

对没有明确呼吸功能障碍的住院患者尽早进行吸气肌训练,可以预防因长期住院导致呼吸肌质量下降而直接或间接引发的院内不良后果。本临床试验的目的是评估吸气肌训练对住院患者并发症的影响。

方法

这是一项双盲随机对照试验。干预组的受试者自入组研究起,每天进行两次吸气肌训练,负荷为最大吸气压的50%,持续4周。患者被随机分配至吸气肌训练组或假吸气肌训练组。所有患者均接受常规物理治疗干预。评估基线及干预后的呼吸和外周肌肉力量、功能(日常生活活动能力)、住院时间及死亡率。直至患者出院评估临床结局。本研究经机构医院伦理委员会批准(03/2014)。

结果

分析了31例分配至吸气肌训练组和34例分配至假吸气肌训练组的患者。吸气肌训练组患者的平均住院时间较短(35.3±2.7天 vs. 41.8±3.5天,p<0.01),气管插管风险较低(相对风险(RR)=0.36;95%置信区间(CI)0.27 - 0.97;p = 0.03),肌肉无力风险(RR = 0.36;95%CI 0.19 - 0.98;p = 0.02)及死亡率(RR = 0.23;95%CI 0.2 - 0.94;p = 0.04)也较低。两组间不良事件风险无显著差异。

结论

吸气肌训练是预防气管插管、肌肉无力和死亡的保护因素。

试验注册

ClinicalTrials.gov,标识符:NCT02459444。于2015年5月19日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2bb/5745884/10700835f3f5/13063_2017_2372_Fig1_HTML.jpg

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