Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Pulmonary Complications (PPCs)
研究概览
简要总结
Title of Study:
A New Nursing System to Help Lung Recovery After Brain Tumor Surgery
Why was this study done? After surgery for a brain tumor (craniocerebral tumor), some patients develop lung problems like pneumonia or collapsed lung areas (atelectasis). These problems can slow down recovery, keep patients in the hospital longer, and make them feel worse. Doctors and nurses wanted to find a better way to protect the lungs and help patients breathe easier after surgery.
What did the researchers want to find out? They wanted to see if a special, step-by-step nursing system for lung recovery-called the Perioperative Pulmonary Rehabilitation Nursing System (PPRNS) -could reduce lung problems after brain tumor surgery and help patients get back on their feet faster.
What was done in the study?
Who: 165 patients having brain tumor surgery at one hospital.
How: Patients were put into two groups by chance (like flipping a coin):
Control group (81 patients): Received regular, standard care after surgery.
Intervention group (84 patients): Received the new PPRNS care. This included:
Before surgery: Breathing exercises, learning to cough effectively, and nutrition advice.
During surgery: Lung-protective methods by the anesthesia team.
After surgery: Deep breathing exercises, sitting up and moving early, help clearing mucus from the lungs, and close monitoring.
What was measured: The main thing measured was how many patients developed lung problems (like pneumonia) within 14 days after surgery. They also checked lung function, how fast patients recovered (walking, eating, removing tubes), length of hospital stay, and patient satisfaction.
What were the main results?
Fewer lung problems: Only 4.8% of patients in the new care group developed lung complications, compared to 13.6% in the regular care group. This means the new system cut lung problems by more than half.
Better breathing: Patients in the new care group had stronger lung function tests (FVC, PEF) and higher oxygen levels after surgery.
Faster recovery: They got off breathing tubes earlier, started walking sooner, cou
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years, inclusive
- •Preoperative diagnosis of intracranial tumor confirmed by imaging and/or pathology per WHO Classification of Tumours of the Central Nervous System (5th edition), with planned craniotomy for tumor resection (initial or recurrent surgery)
- •Preoperative assessment confirms ability to cooperate with pulmonary rehabilitation training (adequate consciousness, cognition, and communication for short-term training)
- •Voluntary participation with written informed consent
排除标准
- •Pre-existing severe chronic obstructive pulmonary disease (COPD GOLD stages 3-4)
- •Pre-existing severe interstitial lung disease
- •Requirement for long-term oxygen therapy
- •Pneumonia or respiratory failure requiring mechanical ventilation within one month prior to surgery
- •Severe cardiac dysfunction (New York Heart Association class III-IV)
- •Other major organ insufficiency
- •Severe impairment of consciousness
- •Inability to follow commands
- •Language barriers
- •Life expectancy less than 30 days
- •Concurrent participation in other interventional studies that could confound pulmonary function outcomes
研究组 & 干预措施
The intervention group
干预措施: intervention group (Behavioral)
The control group
结局指标
主要结局
Incidence of Postoperative Pulmonary Complications (PPCs)
时间窗: Within 14 days post-surgery
Description: The occurrence of respiratory system-related complications, including but not limited to: Pneumonia (diagnosed based on clinical symptoms, laboratory findings, and radiographic evidence: fever, purulent sputum, pulmonary rales, new infiltrates on chest X-ray or CT) Atelectasis (confirmed radiographically) Severe hypoxemia requiring intervention Airway spasm Aspiration
次要结局
- Forced Vital Capacity (FVC)(Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge))
- Recovery Metrics (Functional Recovery Indicators)(From surgery end until achievement (measured in hours or days))
- Postoperative Length of Hospital Stay(At hospital discharge, assessed through study completion (average of 14 days))
- Incidence of Other (Non-Pulmonary) Complications(Within 14 days post-surgery)
- Postoperative Length of Hospital Stay(At hospital discharge, assessed through study completion (average of 14 days post-surgery))
- Patient Satisfaction with Nursing Care(At hospital discharge (average of 14 days post-surgery))
- Peak Expiratory Flow (PEF)(Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge))
- Peripheral Oxygen Saturation (SpO₂)(Preoperative, postoperative day 1, and postoperative day 3)
- Barthel Index Score(At hospital discharge (average of 14 days post-surgery))
- 36-Item Short Form Health Survey (SF-36) Total Score(At hospital discharge (average of 14 days post-surgery))
- Forced Vital Capacity (FVC)(Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge))
- Time to First Ambulation(From surgery end to first ambulation, assessed up to 14 days post-surgery)
- Time to First Effective Autonomous Cough(From surgery end to first effective cough, assessed up to 7 days post-surgery)
研究者
Haiyan Qiu
Principal Investigator
The Affiliated Brain Hospital of Nanjing Medical University