Pulmonary Complications in Surgical PatientsNCT07208500
Effect of Delayed Remote Ischemic Preconditioning on Postoperative Pulmonary Complications in Elderly Patients Having Non-Cardiac Thoracic Surgery
A study testing RIPC in people with Pulmonary Complications in Surgical Patients, run by Shanghai Geriatric Medical Center at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Complications in Surgical Patients
- What is being tested?
- RIPC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Geriatric Medical Center
Shanghai
Xue Clinical Research Coordinator, 021-31118563, zx02190554@163.com
About this study
Official title: The Effect of Delayed Remote Ischemic Preconditioning on Postoperative Pulmonary Complications in Elderly Patients Undergoing Non-Cardiac Thoracic Surgery
Study Summary: The Effect of a Simple Arm Cuff Procedure on Lung Complications After Surgery in Older Adults
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- RIPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPCProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start6 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Complications in Surgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Geriatric Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Zhang, Shanghai Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208500
- Sponsor's protocol ID
- B2025-038R
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Delayed Remote Ischemic Preconditioning on Postoperative Pulmonary Complications in Elderly Patients Undergoing Non-Cardiac Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07208500
- Acronym / sponsor ID
- B2025-038R
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Shanghai Geriatric Medical CenterUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Summary: The Effect of a Simple Arm Cuff Procedure on Lung Complications After Surgery in Older Adults
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC Group | Experimental | Procedure: RIPCInflate 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 | Sham comparator | Procedure: RIPCInflate 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPCInflate 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 or surgery | Control Group, RIPC Group |
Primary outcome
The incidence rate of pulmonary complications 7 days after surgery
Time frame: 7 days after surgery
Postoperative pulmonary complications include: atelectasis, respiratory tract infection, respiratory failure, empyema, pulmonary embolism, bronchopleural fistula, and pneumothorax.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC in people with Pulmonary Complications in Surgical Patients, run by Shanghai Geriatric Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Zhang (02164175590, zx02190554@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of pulmonary complications 7 days after surgery (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.