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临床试验/NCT03356496
NCT03356496撤回不适用

Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications After Non-cardiothoracic Surgery

Medical College of Wisconsin2 个研究点 分布在 1 个国家开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Postoperative pulmonary complications

研究概览

简要总结

Postoperative pulmonary complications (PPCs) are a source of much morbidity and mortality. Rates of PPCs exceed 30% in patients with multiple risk factors. Several studies have demonstrated reduced PPCs in patients who underwent preoperative inspiratory muscle training. These studies largely focused on cardiothoracic surgery and required the use of respiratory therapists. The investigators hypothesize that preoperative, self-administered respiratory therapy would reduce PPCs in patients with risk factors for PPCs undergoing any non-cardiothoracic surgery. This study is a randomized, controlled trial comparing preoperative use of an incentive spirometry device with usual care in patients undergoing non-emergent, non-cardiothoracic surgical procedures under general anesthesia.

详细描述

Postoperative pulmonary complications account for >50% of all adverse postoperative events and are more costly and carry greater comorbidity than cardiac complications. Much research has been performed to identify potential risk reduction strategies for PPCs. Until recently all of these focused on intraoperative and postoperative interventions, including lung-protective mechanical ventilation, lung expansion techniques, and use of regional anesthesia and analgesia. In the last few years several studies have investigated the potential role of preoperative interventions to improve respiratory status. These studies have demonstrated benefit from preoperative inspiratory muscle training (IMT). A recent systematic review found that any preoperative intervention, such as education, IMT, exercise training or relaxation reduced PPC rates. However, these studies have focused on cardiothoracic and abdominal surgery, and almost all have utilized respiratory therapist-directed interventions. Likely due to the additional costs and difficulty of arranging respiratory therapy on an outpatient basis, this promising new risk mitigation strategy has yet to be adopted on a large scale. Incentive spirometry devices offer a potentially easier and less costly preoperative respiratory intervention. Incentive spirometers are a drug-free, easy to use, hand-held device that promotes deep breathing and respiratory muscle strength by providing visual feedback during sustained inhalation. It opens weak or collapsed airways to mobilize and assist mucociliary clearance to the upper airways where it can be coughed out. This study evaluates the hypothesis that providing preoperative, patient self-directed respiratory therapy with use of an incentive spirometry device will reduce the incidence of PPCs in patients with increased pulmonary risk undergoing any major, non-cardiothoracic surgery with general anesthesia.

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

入选标准

  • Intermediate or high risk for postoperative pulmonary complications as defined by ARISCAT score >25
  • Undergoing non-cardiothoracic surgery scheduled at least 7 days in the future
  • Planned general anesthesia (alone or in combination with regional or neuraxial anesthesia)
  • Personal internet access

排除标准

  • Active bronchospasm during preoperative clinic visit
  • History of pneumothorax
  • History of tracheal stoma or ventilator dependency
  • Pregnancy
  • Chronic oxygen requirement
  • Deficient motor and/or visual function that will prohibit utilization of the device or instructional video and handout
  • Lack of English language proficiency
  • Inability to consent

结局指标

主要结局

Postoperative pulmonary complications

时间窗: Up to 30 days after surgery

Composite of hypoxemia (pulse oximetry \<88% with provision of oxygen therapy beyond 24 hours after surgery); bronchospasm (new wheezing or bronchospasm with provision of bronchodilator therapy); hypercarbia (serum bicarbonate or arterial or end-tidal carbon dioxide level above reference range treated with provision of mechanical ventilation); atelectasis (radiographic evidence of atelectasis plus respiratory symptoms or abnormal lung exam findings); respiratory infection (patient received antibiotics for suspected respiratory infection and had at least 1 of following: new or changed sputum, new or changed lung opacities on chest radiograph, fever, or leukocyte count \>12,000/microliter); pleural effusion (radiographic evidence of pleural effusion and performance of thoracentesis); pneumothorax (radiographic evidence of pneumothorax); and ventilatory failure (replacement of endotracheal tube or mechanical ventilation for \>48 hours postoperatively)

次要结局

  • Unanticipated hospital admissions(Up to 30 days after surgery)
  • Mortality(Up to 30 days after surgery)
  • Unanticipated hospital observation(Up to 30 days after surgery)
  • Length-of-stay(Up to 30 days after surgery)
  • Readmission(Up to 30 days after surgery)
  • Unanticipated intensive care unit utilization(Up to 30 days after surgery)

研究者

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

Hari Paudel

Assistant Professor of Medicine

Medical College of Wisconsin

研究点 (2)

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