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Effects of Comprehensive Lung-Protective Interventions on Postoperative Pulmonary Complications in Patients Undergoing Open-Heart Valve Surgery

Effects of Comprehensive Lung-Protective Interventions on Postoperative Pulmonary Complications in Patients Undergoing Open-Heart Valve Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110021
Enrollment
Unknown
Registered
2025-09-29
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular heart disease

Interventions

Group E :Comprehensive Lung Protection Interventions
Group A :No intervention measures
Group B :Oral care and pulmonary prehabilitation education.
Group C :Intraoperative lung-protective ventilation (LPV)
Group D:Continuous intravenous infusion of sivelestat sodium at 4.8 mg·kg?1

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: Age >=18 years; 2: Scheduled for median sternotomy valve surgery under CPB; 3: Cardiac function (NYHA class) II–III; 4: Written informed consent obtained from patients or legal representatives.

Exclusion criteria

Exclusion criteria: 1: Severe non-cardiac pulmonary disease; 2: Acute respiratory infection within 1 month preoperatively, with symptom resolution 35 kg/m² or obstructive sleep apnea syndrome; 7: Inability to communicate (coma, severe dementia, or language barrier); 8: Re-do open-heart surgery under CPB; 9: Participation in other interventional trials or experimental drug use within 3 months; 10: Poor compliance or inability to complete the trial.

Design outcomes

Primary

MeasureTime frame
PPC incidence within 7 days postoperatively ;

Secondary

MeasureTime frame
Postoperative ventilator use time;Length of hospital stay;Postoperative extrapulmonary complications;28-day postoperative mortality rate;Plasma levels of TNF-a, IL-6, IL-8, and IL-10 at 24 and 48 hours after surgery;Plasma levels of sRAGE, CC16, and Ang-2 at 24 and 48 hours after surgery;

Countries

China

Contacts

Public ContactZhou Lifang

The First Affiliated Hospital of Guangxi Medical University

395270146@qq.com+86 183 7881 1663

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026