Department of Medicine, Section of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, 840 S, Wood Street, Chicago, Illinois 60612, USA.
Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120.
High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).
Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.
Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes.
HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population.
ClinicalTrials.gov: NCT00181285.
高频胸壁振荡(HFCWO)用于清除气道黏液。本研究的目的是评估在急性哮喘或慢性阻塞性肺疾病(COPD)住院患者中早期使用 HFCWO 的效果。
在四个学术医疗中心,对急性哮喘或 COPD 住院患者在入院后 24 小时内进行随机、多中心、双盲 II 期临床试验,进行活性或假治疗。患者接受活性或假治疗,每天 3 次,每次 15 分钟,共 4 次。各组的医疗管理均标准化。主要结局是 4 次治疗后(使用分钟数/规定分钟数)患者对治疗的依从性和满意度。次要结局包括 Borg 呼吸困难评分的变化(≥ 1 单位表示临床显著变化)、自发咳出的痰液量和 1 秒用力呼气量。
52 名患者被随机分配至活性(n = 25)或假(n = 27)治疗组。两组患者的依从性均较高(91% vs. 93%;p = 0.70)。两组患者的满意度也相似。经过 4 次治疗,活性治疗组中有更高比例的患者呼吸困难有临床显著改善(70.8% vs. 42.3%,p = 0.04)。其他次要结局无显著差异。
HFCWO 在急性哮喘或 COPD 住院患者中耐受性良好,可显著改善呼吸困难。两组患者的满意度均较高,因此在评估 HFCWO 对患者报告结局的影响时,需要设置假对照。需要进一步研究来更全面地评估 HFCWO 在改善该人群住院和出院后结局方面的作用。
ClinicalTrials.gov:NCT00181285。