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

NCT07208500 | Recruiting

• 1 other identifier: B2025-038R
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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.
3. 3.Who can participate?
4. 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.
5. 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.
6. 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.

Conditions

Pulmonary Complications in Surgical Patients

Outcome Measures

Primary Outcomes (1)

• The incidence rate of pulmonary complications 7 days after surgery

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

  7 days after surgery

Study Arms (2)

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.

Procedure: RIPC

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.

Procedure: RIPC

Interventions

RIPC PROCEDURE

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.

Control Group; RIPC Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Geriatric Medical Center: lead

Study Sites (1)

Shanghai Geriatric Medical Center

Shanghai, China

RECRUITING

Central Study Contacts

Xue Zhang

CONTACT

02164175590; zx02190554@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)