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临床试验/NCT06001411
NCT06001411尚未招募不适用

Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Colorectal Surgery

Min Su1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
The incidence of postoperative pulmonary complications(PPCs)

研究概览

简要总结

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery and so on. However, relevant studies have shown that postoperative pulmonary complications are more common in patients undergoing Laparoscopic Colorectal Surgery, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption.

The incidence of pulmonary complications after abdominal surgery has been reported to be between 9% and 40%.

The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, long-term bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of postoperative pulmonary complications.

Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation. So, the purpose of this study is to observe whether preoperative prone position training can reduce the incidence of pulmonary complications after laparoscopic colorectal cancer surgery.

详细描述

Colorectal cancer is a common digestive tract tumor in China. At present, laparoscopic surgery has become the classic operation of colorectal cancer surgery compared with the traditional open abdominal surgery. Although laparoscopic surgery has many advantages, such as less pain, faster recovery. However, relevant studies have shown that postoperative pulmonary complications are more common in patients undergoing Laparoscopic Colorectal Surgery, which contribute to significant increases in morbidity, mortality, length of postoperative hospital stay and medical consumption.

Postoperative pulmonary complications (PPCs) refer to the clinical abnormal changes in the lungs after surgery, These include lung infections (pneumonia), atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory distress syndrome (ARDS). The incidence of pulmonary complications after abdominal surgery has been reported to be between 9% and 40%.

The reduction in pulmonary volume and respiratory muscular activation after major abdominal surgery due to surgery-related shallow breathing, pain, long-term bed rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of postoperative pulmonary complications.

Numerous studies have demonstrated physiological improvement related to prone positioning. Prone positioning consists of placing a patient face down. Prone positioning has been used for more than 40 years to improve oxygenation in patients who require invasive mechanical ventilation for acute respiratory distress syndrome (ARDS). Because of the positive physiological effects of prone positioning on transpulmonary pressure, lung compression and ventilation perfusion ratio, it has also been applied to non-intubated patients with acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for invasive ventilation.

Currently, the mechanisms of prone position training are decreased lung compression in the gravity dependant zone,homogenisation of transpulmonary pressure, improvement of ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position, the lungs compression due to its own weight is reduced via a gravitational-dependent redistribution of fluids. In addition, the weight of the mediastinum is supported by the sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral one resulting in a more aerated lung in prone positioning.

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
Single (Participant)

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

  • •age over 18 years old
  • •Clinical diagnosis of colorectal cancer

排除标准

  • •Emergency surgery
  • •Cognitive dysfunction
  • •American Society of Anesthesiologists class ⩾IV
  • •Fractures (face, collarbone, ribs, spine, limbs)
  • •History of spontaneous pneumothorax
  • •Increased intracranial pressure
  • •pregnancy
  • •Systemic infection
  • •Acute respiratory failure
  • •Patients with hemodynamic instability
  • •Other conditions that are not suitable for prone position
  • •Failure to obtain informed consent

研究组 & 干预措施

Prone Position Training group (PPT group)

Experimental

All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.

干预措施: Prone Position Training (Behavioral)

Control group (C group)

Placebo Comparator

Patients in the control group (C group) received standard perioperative care without any prone position training.

干预措施: control group (Behavioral)

结局指标

主要结局

The incidence of postoperative pulmonary complications(PPCs)

时间窗: 7 day after surgery

The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations

次要结局

  • arterial partial pressure of oxygen (PaO2)(preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery)
  • extubation time(Day of surgery)
  • Peak airway pressure(Intraoperative)
  • oxygenation index (OI)(preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery)
  • arterial partial pressure of carbon dioxide (PaCO2)(preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery)

研究者

发起方
Min Su
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min Su

Professor of Anesthesiology

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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