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临床试验/NCT05519657
NCT05519657Unknown不适用

Incidence and Risk Factors of Postoperative Pulmonary Complications in Elderly Patients Undergoing Robot Assisted Laparoscopic Pelvic Surgery: a Single Center, Prospective, Observational Study

Tongji Hospital0 个研究点目标入组 154 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
154
主要终点
Incidence of PPCs

研究概览

简要总结

Postoperative pulmonary complications are important factors affecting the prognosis of patients undergoing surgery. Studies have shown that patients undergoing abdominal or pelvic surgery, emergency surgery, or prolonged surgery are more likely to develop PPCs, especially when robot-assisted laparoscopic surgery is performed at extreme head low. The incidence of PPCs and associated risk factors in patients undergoing robot-assisted laparoscopic surgery compared with those undergoing conventional surgery should be re-examined.

详细描述

PPCs include bronchospasm, atelectasis, lung infections (bronchitis and pneumonia), exacerbation of pre-existing chronic lung disease, the need for mechanical ventilation after surgery, and respiratory failure. Risk factors for PPCs include preoperative and intraoperative factors. Preoperative was mainly related to the primary status of patients, including age, weight, ASA grade, organ function status, medication history, hypoproteinemia, and concomitant chronic kidney disease, congestive heart failure, COPD, asthma, pulmonary interstitial disease, pulmonary hypertension, and OSA. In this study, elderly patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia were selected to prospectively collect basic characteristics, preoperative examination results and perioperative data, and determine the incidence and risk factors of PPCs in this high-risk population cohort. The aim of our study was to determine the incidence of PPCs in elderly patients undergoing robot-assisted laparoscopic pelvic surgery and to screen for associated risk factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥65 years old
  • Selective patients undergoing robot-assisted laparoscopic pelvic surgery under general anesthesia

排除标准

  • Patients undergoing oxygen therapy or mechanical ventilation before surgery
  • Patients who have received other surgical operations within 30 days
  • Patients who have previously undergone lung surgery

结局指标

主要结局

Incidence of PPCs

时间窗: Up to 7 days

One or more of the following conditions occurred: clinically diagnosed PPCs (pneumonia, bronchospasm, ARDS), radiographically diagnosed PPCs (atelectasis, pneumothorax, pleural effusion), postoperative respiratory insufficiency (requiring oxygen or non-invasive mechanical ventilation for more than 1 day), and postoperative tracheal intubation again;Respiratory infections: new or altered sputum properties, new or altered lung shadows, fever, white blood cell \>12 × 109/L;Respiratory failure: partial pressure of oxygen in the arterial blood while inhaling air\< 60 mmHg, pulse oxygen saturation\< 90%, or PaO2/FiO2 \< 300;Atelectasis, pneumothorax, pleural effusion: Chest X - ray diagnosis;Bronchospasm: wheezing sound can be relieved with bronchodilators.

次要结局

  • Risk factors of PPCs(Up to 7 days)

研究者

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

Feng Gao

Professor

Tongji Hospital

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