A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative pulmonary complication
研究概览
简要总结
Patients at high risk of post-operative pulmonary complications (PPC) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the HFNC group and control group, which uses conventional nasal cannula oxygen therapy. The primary outcome is the incidence of PPC, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.
详细描述
This randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. The study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. Secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met:
- •Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points;
- •Moderate to severe asthma;
- •Moderate to severe chronic obstructive pulmonary disease (COPD);
- •Smoking history ≥20 packs/year
排除标准
- •Patients with lung metastasis of malignant tumor or primary lung malignant tumor;
- •previous lung surgery or radiotherapy;
- •the surgery involved segmental bowel resection.
研究组 & 干预措施
HFNC group
HFNC group was given heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery to maintain oxygen saturation at 92% ~ 95%.Chest CT was reviewed 36-48 hours after surgery.
干预措施: heated humidified high flow nasal cannula oxygen therapy, HFNC (Device)
Control group
The control group was given conventional nasal catheter oxygen inhalation on the day of surgery and the first day after surgery, and oxygen flow was adjusted to maintain oxygen saturation at 92% ~ 95%.Chest CT was reviewed 36-48 hours after surgery.
干预措施: Nasal cannula oxygen (Device)
结局指标
主要结局
Postoperative pulmonary complication
时间窗: 7 days after the surgery
The primary outcome measures were the incidence of PPC in the treatment group and the control group, including the incidence of postoperative hypoxemia, atelectasis, pneumonia, etc.
次要结局
- Antibiotics(7 days after the surgery)
- Postoperative oxygenation(2 days after the surgery)
- Total Hospitalization days(7 days after the surgery)
- Oxygen therapy(2 days after the surgery)
- Adverse events(2 days after the surgery)
研究者
Dengfeng Wang
Attending Physician
Sichuan Cancer Hospital and Research Institute