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Adults with cystic fibrosis prefer hypertonic saline before or during airway clearance techniques: a randomised crossover trial

机译:患有囊性纤维化的成年人在气道清除术之前或期间更喜欢高渗盐水:一项随机交叉试验

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Question Among adults with cystic fibrosis, does the timing of hypertonic saline relative to airway clearance techniques affect lung function, perceived efficacy, tolerability, or satisfaction with the entire airway clearance regimen, and is the preferred timing regimen stable over time? Design A randomised crossover trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants 50 adults with cystic fibrosis and stable lung function at the end of a hospital admission. Intervention Participants performed 3 sessions of airway clearance techniques per day for 3 days. On each day, participants were randomised to inhale hypertonic saline either before, during, or after the airway clearance techniques. Participants readmitted within one year repeated the 3-day study. Outcome measures The primary outcome was the change in forced expiratory volume in one second (FEV 1 ) from before to 2 hours after an entire airway clearance session. Secondary outcomes were change in forced vital capacity, perceived efficacy, tolerability, satisfaction, adverse events, and adherence. Results All 50 participants completed the study. The effects on lung function were non-significant or were of borderline statistical significance favouring inhalation of hypertonic saline before airway clearance techniques. Satisfaction was rated significantly worse on a 100mm scale when hypertonic saline was inhaled after the airway clearance techniques: mean differences 20mm (95% CI 12 to 29) compared to before the airway clearance techniques and 15mm (95% CI 6 to 24) compared to during the techniques. Perceived effectiveness showed similar effects but other outcomes were unaffected. All 14 participants who were readmitted repeated the study and most preferred the same timing regimen. Conclusion People with cystic fibrosis could be encouraged to time hypertonic saline before or during airway clearance techniques to maximise perceived efficacy and satisfaction, even though lung function may not be better with these timing regimens. Trial registration ACTRN12611000673943.
机译:问题在患有囊性纤维化的成年人中,相对于气道清除技术而言,高渗盐水的时间是否会影响肺功能,感知的疗效,耐受性或对整个气道清除方案的满意度,并且首选的时间选择方案随时间推移是否稳定?设计一项随机交叉试验,包括隐蔽分配,意向性治疗分析和盲目评估者。入院结束时有50名患有囊性纤维化和稳定肺功能的成年人。干预参与者每天进行3次气道清理技术,持续3天。每天,参与者被随机分配在气道清除技术之前,之中或之后吸入高渗盐水。一年内重新入学的参与者重复了为期3天的研究。结果措施主要结果是整个呼吸道通畅会话前一秒钟至2小时后一秒钟的强迫呼气量(FEV 1)改变。次要结果是强迫肺活量,知觉功效,耐受性,满意度,不良事件和依从性的变化。结果所有50名参与者完成了研究。对肺功能的影响不显着或具有统计学意义,有利于在通气道清除术前吸入高渗盐水。气道清除技术后吸入高渗盐水的满意度在100mm范围内显着降低:与气道清除技术之前相比,平均差异为20mm(95%CI 12至29),与15mm(95%CI 6至24)相比在技​​术上。感知到的效果显示出相似的效果,但其他结果未受影响。被重新录取的所有14名参与者都重复了这项研究,并且最喜欢采用相同的计时方案。结论囊性纤维化患者应鼓励在气道清除术之前或期间进行高渗盐水定时治疗,以最大程度地提高疗效和满意度,尽管这些定时方案可能不能使肺功能更好。试用注册ACTRN12611000673943。

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