跳至主要内容
临床试验/NCT07208500
NCT07208500招募中不适用

The Effect of Delayed Remote Ischemic Preconditioning on Postoperative Pulmonary Complications in Elderly Patients Undergoing Non-Cardiac Thoracic Surgery

Shanghai Geriatric Medical Center1 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2025年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
390
试验地点
1
主要终点
The incidence rate of pulmonary complications 7 days after surgery

研究概览

简要总结

Study Summary: The Effect of a Simple Arm Cuff Procedure on Lung Complications After Surgery in Older Adults

  1. What is the purpose of this study? This clinical study aims to find out if a simple, non-invasive procedure called Delayed Remote Ischemic Preconditioning (RIPC) can help reduce lung complications (like pneumonia or breathing difficulties) in older patients (aged 65 and above) after non-cardiac and non-chest surgery.
  2. What is the RIPC procedure? RIPC involves briefly and repeatedly applying and releasing pressure on one upper arm using a standard blood pressure cuff. This is done 24 hours before surgery. The goal is to gently stimulate the arm's circulation, which may activate the body's natural protective mechanisms and help protect the lungs during and after surgery.

RIPC Group: The cuff will inflate to a higher pressure (200 mmHg) for 5 minutes, then release for 5 minutes. This cycle repeats 4 times.

Control Group: The cuff will inflate to a very low pressure (20 mmHg) with the same timing, serving as a comparison to see if the higher pressure has a specific effect. 3. Who can participate?

Patients may be eligible if they:

Are 65 years of age or older. Are scheduled for elective non-cardiac, non-chest surgery under general anesthesia, expected to last 1-3 hours.

Are in relatively stable health (ASA physical status I-II). Patients cannot participate if they have certain pre-existing conditions, such as significant heart or lung disease, severe infections, or bleeding disorders. 4. What will happen during the study? Before Surgery: Eligible patients will receive a full explanation and sign a consent form. They will be randomly assigned (like flipping a coin) to either the RIPC group or the Control group. The procedure will be performed 24 hours before surgery. Some blood tests and an ultrasound scan will be done.

During Surgery: Standard anesthesia and surgical care will be provided. After Surgery: We will monitor patients for any lung complications within 7 days after surgery. Additional blood tests and ultrasound scans will be performed to check lung function and look for signs of inflammation. We will also follow up 90 days after surgery to check on their overall recovery. 5. What are the potential benefits and risks? Potential Benefit: Participants may have a lower risk of developing postoperative lung complications. The knowledge gained may help future patients.

Potential Risks: The arm cuff procedure may cause temporary discomfort, numbness, or minor bruising. There is a very small risk of more serious injury to the arm. The study team is trained to minimize these risks and will monitor patients closely. All standard risks associated with surgery and anesthesia still apply. 6. How is patient safety ensured? This study has been carefully reviewed and approved by an Ethics Committee to ensure it is scientifically sound and ethically conducted. Participation is voluntary, and patients can withdraw at any time without affecting their standard medical care. All personal information will be kept confidential. The study is sponsored and led by the Shanghai Geriatric Medical Center.

Study Version: V3.0 (September 2, 2025) Contact: For further questions, please contact the research team at the participating hospital.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Elderly patients aged 65 years and above undergoing non-cardiac and non-thoracic surgery; operation time of 1-3 hours; American Society of Anesthesiologists (ASA) classification from I to II; BMI of 18-30 kg/m².

排除标准

  • •NYHA cardiac function classification is grade II to IV; there is severe respiratory dysfunction before surgery; there is a history of coagulation dysfunction diseases; chemotherapy, radiotherapy or immunotherapy have been received within 3 months; there is systemic or local active infection; there is peripheral vascular disease affecting upper limb blood vessels; antibiotics, non-steroidal anti-inflammatory drugs, or corticosteroids have been taken within the past 3 months.

研究组 & 干预措施

RIPC Group

Experimental

Inflate a standard blood pressure cuff on one upper arm to 200 mmHg, maintain this pressure for 5 minutes, then deflate the cuff and keep it deflated for another 5 minutes. Repeat this process for 4 cycles.

干预措施: RIPC (Procedure)

Control Group

Sham Comparator

Inflate a standard blood pressure cuff on one upper arm to 20 mmHg, maintain this pressure for 5 minutes, then deflate the cuff and keep it deflated for another 5 minutes. Repeat this process for 4 cycles.

干预措施: RIPC (Procedure)

结局指标

主要结局

The incidence rate of pulmonary complications 7 days after surgery

时间窗: 7 days after surgery

Postoperative pulmonary complications include: atelectasis, respiratory tract infection, respiratory failure, empyema, pulmonary embolism, bronchopleural fistula, and pneumothorax.

次要结局

未报告次要终点

研究者

发起方
Shanghai Geriatric Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xue Zhang

Attending Physician

Shanghai Geriatric Medical Center

研究点 (1)

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