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上腹部手术后预防呼吸并发症的术前物理治疗:实用、双盲、多中心随机对照试验。

Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial.

作者信息

Boden Ianthe, Skinner Elizabeth H, Browning Laura, Reeve Julie, Anderson Lesley, Hill Cat, Robertson Iain K, Story David, Denehy Linda

机构信息

Department of Physiotherapy, Launceston General Hospital, Launceston, TAS, 7250, Australia

Department of Physiotherapy, The University of Melbourne, Melbourne, VIC, 3010, Australia.

出版信息

BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.

Abstract

OBJECTIVE

To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.

DESIGN

Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.

SETTING

Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.

PARTICIPANTS

441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial.

INTERVENTIONS

Preoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided.

MAIN OUTCOME MEASURES

The primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months.

RESULTS

The incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected.

CONCLUSION

In a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

摘要

目的

评估术前单次物理治疗对降低上腹部手术后肺部并发症(PPCs)的疗效。

设计

前瞻性、实用性、多中心、患者及评估者双盲、平行组、随机安慰剂对照优效性试验。

地点

澳大利亚和新西兰三家三级公立医院的多学科入院前诊所。

参与者

441名18岁及以上的成年人,他们在择期开放性上腹部大手术六周内,通过隐蔽分配随机分组,接受信息手册(n = 219;对照组)或术前物理治疗(n = 222;干预组),并随访12个月。432人完成试验。

干预措施

术前,参与者接受信息手册(对照组)或额外30分钟的物理治疗教育及呼吸锻炼训练课程(干预组)。教育重点是PPCs及其通过早期活动和术后恢复意识后立即开始的自主呼吸锻炼进行预防。术后,所有参与者接受标准化的早期活动,未提供额外的呼吸物理治疗。

主要结局指标

主要结局是术后14天内使用墨尔本组评分每日评估的PPCs。次要结局是医院获得性肺炎、住院时间、重症监护病房服务的使用情况及住院费用。在六周时测量患者报告的健康相关生活质量、身体功能及出院后并发症,并测量至12个月时的全因死亡率。

结果

与对照组相比,干预组术后14天内PPCs(包括医院获得性肺炎)的发生率减半(调整后风险比0.48,95%置信区间0.30至0.75,P = 0.001),绝对风险降低15%(95%置信区间7%至22%),需治疗人数为7(95%置信区间5至14)。未检测到其他次要结局有显著差异。

结论

在择期上腹部手术患者的总体人群中,在现有医院多学科入院前诊所提供的30分钟术前物理治疗课程可使PPCs尤其是医院获得性肺炎的发生率减半。需要进一步研究以调查对死亡率和住院时间的益处。

试验注册

澳大利亚新西兰临床试验注册中心ANZCTR 12613000664741。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e42/5782401/b3479cbc33d9/bodi041081.f1.jpg

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