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临床试验/NCT07192575
NCT07192575招募中不适用

Enhanced Perioperative Pulmonary Physiotherapy for Prevention of Pulmonary Complications After Laparoscopic Liver Surgery

Oulu University Hospital5 个研究点 分布在 2 个国家目标入组 364 人开始时间: 2024年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
364
试验地点
5
主要终点
Rate of postoperative pulmonary complications (PPCs) within 14 days of operation

研究概览

简要总结

  • Background: Postoperative pulmonary complications (PPCs) are the most common complications after major upper abdominal surgery. PPCs include respiratory infections, severe atelectasis, pleural effusion, bronchospasm, aspiration pneumonitis, pneumothorax, exacerbation of chronic pulmonary condition, and respiratory failure. Although PPC rates are higher after open liver surgery, PPCs still occur in approximately 12-13% of patients undergoing laparoscopic liver surgery. Preoperative respiratory physiotherapy education reduces PPCs after open major abdominal surgery and after laparoscopic colorectal surgery. The aim of this study is to investigate the impact of enhanced perioperative pulmonary physiotherapy on the incidence of PPCs after laparoscopic liver surgery.
  • Methods: A prospective, multicentre, single-blinded, randomized controlled trial will be conducted according to the study protocol at participating centers. A total of 326 patients scheduled for laparoscopic liver surgery will be randomized at a 1:1 ratio into intervention group or standard Enhanced Recovery After Surgery (ERAS) -based perioperative education group. Surgeons/ researchers are blinded to the patient allocation. Patients in the intervention group receive preoperative breathing education in a single session and an educational video to guide pulmonary training at home. Pulmonary training lasts for 7 days prior to surgery and for 7 days postoperatively. The training includes deep breathing, and coughing, pursed lip breathing and positive expiratory pressure (PEP) therapy. Patients receive instructions for conducting exercises along with an individual risk assessment at a preoperative ambulatory visit. The exercise session (10min) is to be performed two times daily for total of 14 days. The control group receives standard perioperative breathing education. Primary outcome is the rate of postoperative pulmonary complications within 14 days of operation. Secondary outcomes include 90-day mortality, Clavien-Dindo classified complications, length of hospital stay, intensive care unit (ICU) stay, and hospital costs.
  • Discussion: Little effort is currently put into preventing pulmonary complications after surgery, although PPCs aggravate considerable morbidity and costs to health care system. ERAS Society protocols concentrate mainly on optimizing postoperative recovery. Laparoscopic techniques as such and frequent manipulation of the diaphragm during liver surgery provoke PPCs at a considerable rate. Aim of the study is to present a short-and-easy perioperative pulmonary physiotherapy initiative and evaluate its impact on PPC rate and PPCs ramifications, including direct costs, after laparoscopic liver surgery.

详细描述

Background: Postoperative pulmonary complications (PPC) are the most common serious complications after major abdominal surgery. PPC rate varies between 10-50% after open abdominal surgery, depending on the definitions used (Miskovic & Lumb, 2017; PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology et al., 2014). According to the European Perioperative Clinical Outcome (EPCO) definition, PPCs enclose clinically relevant pulmonary complications including respiratory infection, atelectasis, pleural effusion, respiratory failure, bronchospasm/ exacerbation of chronic pulmonary condition, pulmonary embolism, aspiration pneumonitis and pneumothorax (Table 1) (Jammer et al., 2015). PPCs cause extensive health care costs due to increased length of stay, ICU days, medication costs, and mortality (Miskovic & Lumb, 2017).

Table 1. Definitions of PPCs (Jammer et al., 2015)

PPCs after abdominal surgery result from shallow breathing due to pain, and abdominal distension, bed rest, long duration of surgery, mucociliary clearance disorder, and dysfunction of diaphragm after mechanical ventilation (Miskovic & Lumb, 2017). Laparoscopic surgery and use of modern Enhanced Recovery After Surgery (ERAS) protocols are associated with reduced PPC rates compared to open surgery, and to poor ERAS compliance (Jurt et al., 2018; Milone et al., 2017). However, PPCs still are the most frequent postoperative complications also after laparoscopic liver surgery, occurring in approximately 12-13% of cases (Fuks et al., 2016; Qin et al., 2021). The relatively high incidence is likely due to laparoscopy and pneumoperitoneum as such, since elevated intra-abdominal pressure accelerates atelectasis formation, decreases respiratory compliance, and causes ventilation/perfusion mismatch, leading to PPCs (Lunardi et al., 2013; Park et al., 2016). PPCs are however more common after laparoscopic liver surgery than after e.g. laparoscopic gastrectomy, where PPC rate is commonly only around 7%(Ntutumu et al., 2016). This implies that specific characteristic of liver surgery, such as manipulation of diaphragm, tendency for postoperative fluid collections under the diaphragm and the disease specific susceptibility of cirrhotic patients for developing PPCs, all most likely affect the higher rate of PPCs after liver surgery.

Different types of interventions have been suggested for preventing PPCs. Preoperative pulmonary physiotherapy education has been shown to reduce PPCs after open major upper abdominal surgery by Boden at al. (Boden et al., 2018). In their RCT of 441 patients, intervention was a single preoperative physiotherapy session, during which the investigators informed the patient about PPCs in general, directed the postoperative physiotherapy exercises, and assessed each patients' individual risk for PPC. The high-quality study showed that this type of small-scale intervention halved the rate of PPCs after open upper abdominal surgery. Cochrane analysis by do Nascimento et al. assessed the effect of incentive spirometry on PPCs compared to no therapy or pulmonary physiotherapy, and found no significant benefit (do Nascimento et al., 2014). Usefulness of perioperative physiotherapy in reducing PPCs after laparoscopic surgery has been studied in two Chinese randomized trials, which both found almost 75% decrease in PPCs in the intervention group (Chen et al., 2022; Qin et al., 2021). The trials were conducted with nearly identical protocols, and by the same research group with patients undergoing laparoscopic colorectal surgery (Qin et al., Chen et al. Clin Rehab 2022). The intervention involved a strenuous, and expensive in-hospital physiotherapy for five days prior to surgery and home-bound pulmonary training for 90 postoperative days.

Prehabilitation programs are recognized as potentially beneficial in avoiding postoperative complications and reducing health care costs (Sliwinski et al., 2023). Protocols in prevention of PPCs are however highly heterogeneous and complex programs and generate a need for extra staff for execution in clinical practice. Research concerning prehabilitation has been criticized for discrepant outcome and methodology measures (Sliwinski et al., 2023), and this also concerns PPC prevention studies. At the moment, no evidence exists on prevention measures to reduce PPCs after any type of laparoscopic upper abdominal surgery. Previous studies on the prevention of PPCs after laparoscopic colorectal surgery present programs that cannot be reasonably integrated to current practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who undergo elective, laparoscopic surgery of liver
  • •Patients who are able to provide informed written consent
  • •Patients capable of completing questionnaires at the time of consent
  • •Patients compliant in taking in preoperative pulmonary counseling and conducting the exercises

排除标准

  • •Age <18 years
  • •Emergency surgery
  • •Planned open surgery
  • •Unwillingness to participate in the follow up assessment
  • •No informed consent

研究组 & 干预措施

Control arm

No Intervention

The control group receives standard perioperative breathing education.

Perioperative pulmonary physiotherapy arm

Active Comparator

Patients in the intervention group receive preoperative breathing education in a single session and an educational video to guide pulmonary training at home. Pulmonary training lasts for 7 days prior to surgery and for 7 days postoperatively. The training includes deep breathing, and coughing, pursed lip breathing and positive expiratory pressure (PEP) therapy. The exercise session (10min) is to be performed two times daily for total of 14 days.

干预措施: Perioperative Pulmonary Physiotherapy in Laparoscopic Liver Surgery (Behavioral)

结局指标

主要结局

Rate of postoperative pulmonary complications (PPCs) within 14 days of operation

时间窗: Complications recorded until 14 days postoperatively

PPC is diagnosed when four or more of the following criteria were present: * Chest radiograph report of collapse/consolidation/ clinically relevant effusion/ edema * Raised maximum oral temperature \> 38o C on more than one consecutive postoperative day * Pulse oximetry oxygen saturation (SpO2) \< 90% on more than one consecutive postoperative day * Production of yellow or green sputum different to preoperative assessment * Presence of infection on sputum culture report * An otherwise unexplained white cell count greater than 11 x 109/l or prescription of an antibiotic specific for respiratory infection * New abnormal breath sounds on auscultation different to preoperative assessment * Physician's diagnosis of postoperative pulmonary complication * Presence of pneumonia, bronchitis or clinically relevant effusion/edema on computed chest tomography * Presence of pulmonary embolism (PE) on computed chest tomography * Exacerbation of chronic pulmonary condition (defined as a need to

次要结局

  • Length of stay(90 days postoperatively)
  • Postoperative complications(90 days postoperatively)
  • Direct hospital costs(90 days postoperatively)
  • Postoperative mortality(90days postoperatively)
  • Length of intensive care unit (ICU) stay(90days post operatively)
  • Use of antibiotics postoperatively(90 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Minna Nortunen

Md PhD, consultant HPB surgeon

Oulu University Hospital

研究点 (5)

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