Comparing new and traditional breathing methods for elderly patients during surgery
Comparing the Effects of Innovative and Traditional Lung-protective Ventilation Strategies on the Occurrence of Perioperative Atelectasis and Prognosis in Elderly Patients: a Prospective, Randomized, Controlled Study
This study tests whether new breathing methods can help older patients have fewer lung problems and recover better after surgery compared to traditional techniques.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 60 Years to 100 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Locations | 3 sites (Fuzhou, Fujian and 2 other locations) |
| Trial ID | NCT06021249 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of innovative lung-protective ventilation strategies compared to traditional methods in reducing atelectasis and postoperative complications in elderly patients undergoing general anesthesia surgery. It employs a factorial design to assess the impact of these strategies on ventilator-associated lung injury and overall prognosis. The research focuses on critical periods of extubation and post-extubation, integrating positive pressure extubation technology with enhanced early postoperative respiratory training. The aim is to improve recovery outcomes for elderly patients who are at higher risk for pulmonary complications.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 years and older who are undergoing laparoscopic abdominal surgery.
Not a fit: Patients with severe respiratory conditions, recent acute infections, or significant heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative pulmonary complications in elderly patients, leading to shorter hospital stays and improved recovery.
How similar studies have performed: Other studies have shown promising results with innovative ventilation strategies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Elderly patients aged ≥ 60 years old who undergo laparoscopic abdominal surgery； 2. Body mass index（BMI） \<30； 3. American society of anesthesiologists physical status classification system（ASA）:I-III； 4. When the patient inhales air before surgery, SPO2≥94%； 5. The duration of the operation is 2-7 hours, and the pneumoperitoneal pressure is 10-14mmHg. Exclusion Criteria: 1. Patients with acute respiratory distress syndrome or pulmonary hypertension (pulmonary systolic blood pressure ≥ 40mmHg) or bronchiectasis or lung malignant tumors 2. Patients with acute respiratory infections within one month before surgery 3. Patients who have undergone cardiopulmonary surgery 4. Receiving invasive mechanical ventilation for more than 30min within 30 days before surgery 5. Patients with peak airway pressure \> 35 cm H2O during intraoperative mechanical ventilation 6. Patients with severe organic lesions of the heart such as obvious heart failure and coronary heart disease 7. Patients with preoperative anemia (Hb\<10g/L) 8. Patients with hypoproteinemia before surgery (albumin \< 35 g/L) 9. Patients with tracheostomy and severe difficult airway 10. Patients with sleep apnea syndrome 11. Patients with intraoperative heavy bleeding (50% of the circulating blood volume is lost ≥ 3 hours) 12. Patients with mental illness, impaired consciousness and communication disorders 13. Patients who refuse to participate in this trial
Where this trial is running
Fuzhou, Fujian and 2 other locations
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
- The First Hospital of Putian — Putian, Fujian, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Principal investigator: Zhongmeng Lai — Fujian Medical University Union Hospital
- Study coordinator: Lingli Pan
- Email: panlin199104@163.com
- Phone: +86 18065184976
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.