Delayed arm-cuff conditioning to reduce lung complications after non-cardiac, non-thoracic surgery in older adults
The Effect of Delayed Remote Ischemic Preconditioning on Postoperative Pulmonary Complications in Elderly Patients Undergoing Non-Cardiac Thoracic Surgery
This study will test whether inflating a blood-pressure cuff on the arm in short cycles about 24 hours before surgery can lower the risk of lung problems after surgery in people aged 65 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Shanghai Geriatric Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07208500 on ClinicalTrials.gov |
What this trial studies
This interventional study applies delayed remote ischemic preconditioning (RIPC) — repeated short inflations and deflations of an upper-arm cuff performed 24 hours before surgery — and compares it to a low-pressure sham procedure. The active RIPC protocol inflates the cuff to about 200 mmHg for 5 minutes followed by 5 minutes of deflation, repeated four times. Participants are assigned to receive either the RIPC or the sham procedure before undergoing non-cardiac, non-thoracic operations lasting 1–3 hours, and will be followed for postoperative pulmonary complications such as pneumonia or respiratory failure. The trial enrolls older adults (65+) meeting ASA I–II and BMI 18–30 kg/m², with prespecified medical exclusions, and is conducted at Shanghai Geriatric Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older with ASA physical status I–II, BMI 18–30 kg/m², scheduled for a 1–3 hour non-cardiac, non-thoracic operation who can attend a preoperative cuff procedure 24 hours before surgery.
Not a fit: Patients with significant preoperative respiratory dysfunction, moderate-to-severe heart failure (NYHA II–IV), peripheral vascular disease of the upper limb, recent chemotherapy/radiotherapy/immunotherapy, recent systemic infection, coagulation disorders, or recent use of antibiotics, NSAIDs, or corticosteroids are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, this simple, noninvasive, and low-cost arm-cuff procedure could reduce postoperative lung complications and related recovery time for older surgical patients.
How similar studies have performed: Remote ischemic preconditioning has shown organ-protective effects in some cardiac and vascular settings, but evidence for preventing postoperative lung complications is limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Shanghai
- Shanghai Geriatric Medical Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Xue Zhang
- Email: zx02190554@126.com
- Phone: 02164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.