Research
Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial
Ianthe Boden, Elizabeth H Skinner, Laura Browning, et al
BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.j5916 (Published 24 January 2018)
Cite this as: BMJ 2018;360:j5916
Abstract
Objective 目的
To assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.
评估术前一次理疗降低上腹部手术后肺部并发症(PPCs)的疗效。
Design 设计
Prospective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.
前瞻性、实效、多中心、患者及评估者设盲、平行对照、随机安慰剂对照优效研究。
Setting 场景
Multidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.
澳大利亚和新西兰3所三级医院入院前多学科门诊
Participants 研究对象
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.
441名18岁以上成年患者拟在6周内进行择期上腹部开腹手术。患者在分配隐藏的情况下被随机分为接到说明书(n = 219;对照组)或接受术前理疗(n = 222;干预组),随访12个月。432名患者完成试验。
Interventions 干预
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.
患者术前收到一份说明书(对照组),或额外进行30分钟理疗宣教及呼吸训练(干预组)。宣教强调术后一旦恢复意识,立即开始早期活动和自我指导的呼吸锻炼对于预防PPC的重要性。术后,所有患者接受标准化早期活动,不进行额外的呼吸理疗。
Main outcome measures 主要预后指标
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.
主要预后指标为术后14天内PPC,采用Melbourne小组评分每日进行评估。次要预后指标包括医院获得性肺炎,住院日,收入ICU及住院费用。在6周随访时评价患者报告健康相关生活质量,机体功能状态及出院后并发症。12个月随访时评估全因病死率。
Results 结果
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.
与对照组相比,干预组患者术后14天内PPCs(包括医院获得性肺炎)发生率下降一半(校正后风险比0.48, 95% 可信区间 0.30 - 0.75, P=0.001),绝对危险度降低15%(95% 可信区间 7% - 22%),需治数为7 (95% 可信区间 5 - 14)。其他次要预后指标无显著差异。
Conclusion 结论
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.
对于接受择期上腹部手术的一般患者,在入院前多学科门诊进行术前30分钟理疗,能够使PPCs包括医院获得性肺炎的发生率降低一半。需要进一步研究探讨其对病死率及住院日的影响。
Trial registration 试验注册
Australian New Zealand Clinical Trials Registry ANZCTR 12613000664741.