Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Frederiksberg, Denmark
University College Diakonissestiftelsen, Bachelor of Science in Nursing Programme, Danish Deaconess Community, Frederiksberg, Denmark.
BMJ. 2021 Nov 24;375:e066952. doi: 10.1136/bmj-2021-066952.
To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19.
Non-drug, open label, randomised controlled trial.
Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021.
Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19.
Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention.
Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days' follow-up.
378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of -1.2 points (95% confidence interval -2.1 to -0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported.
In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores.
ClinicalTrials.gov NCT04530435.
确定通过使用 PEP 吹管进行自我护理是否能有效减轻社区感染 SARS-CoV-2 病毒和处于早期新冠阶段的成年人的呼吸道症状。
非药物、开放性标签、随机对照试验。
丹麦首都大区和西兰大区，时间为 2020 年 10 月 6 日至 2021 年 2 月 26 日。
能够进行自我护理、新感染 SARS-CoV-2（通过逆转录聚合酶链反应检测证实）并有新冠症状的社区居住成年人。
参与者被随机分配到使用 PEP 吹管进行自我护理（附加于常规护理）或仅接受常规护理。随机分配基于按区组随机化的 1:1 比例，按性别和年龄（<60 岁或≥60 岁）分层。PEP 自我护理组被指示在 30 天的干预期间每天使用 PEP 吹管 3 次。
主要结局是通过自我报告的 COPD（慢性阻塞性肺疾病）评估测试（CAT）评估的症状严重程度从基线到第 30 天的变化，该测试针对基线值和分层因素进行了调整。参与者每天在线完成 CAT 测试问卷。次要结局是 30 天随访内因新冠而紧急就医的自我报告次数、新冠相关症状的数量以及自我评估健康状况的变化。
378 名参与者被分配到 PEP 吹管自我护理干预组（n=190）或仅接受常规护理组（n=188）。在 PEP 自我护理组中，使用 PEP 吹管的中位数天数为 21 天（四分位距 13-25）。对于意向治疗人群，PEP 吹管自我护理组的 CAT 评分从基线变化的组间差异为-1.2 分（95%置信区间-2.1 至-0.2；P=0.017），有利于 PEP 吹管自我护理组。在第 30 天，PEP 吹管自我护理组还报告了较少的胸闷、较少的呼吸困难、更多的活力和更高的日常活动水平，但这些差异较小，次要结局没有一致的效果。没有报告严重不良事件。
在患有早期新冠的社区居住成年人中，PEP 吹管自我护理对 CAT 评分测量的呼吸道症状严重程度具有显著但边际和不确定的临床效果。
ClinicalTrials.gov NCT04530435。
