Optimizing oxygen levels during lung surgery to reduce complications
Titration of Inspired Oxygen During One-lung Ventilation to Decrease the Incidence of Postoperative Pulmonary Complications: a Randomized Controlled Trial
This study tests whether adjusting oxygen levels during lung surgery can help older patients recover better and avoid breathing problems afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06243146 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of titrating inspired oxygen levels during one lung ventilation in patients undergoing thoracoscopic pulmonary resection. Participants will be randomly assigned to either a titration group, where the optimal fraction of inspired oxygen (FiO2) will be determined, or a control group receiving a fixed FiO2 of 80%. The study will assess the incidence of postoperative pulmonary complications, hypoxia/hyperxemia, and other related outcomes to improve patient safety and recovery. The trial focuses on elderly patients who are particularly vulnerable to respiratory complications during surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are undergoing thoracoscopic pulmonary resection and meet specific health criteria.
Not a fit: Patients with pre-existing respiratory conditions or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative pulmonary complications in lung surgery patients.
How similar studies have performed: While the specific approach of titrating oxygen during one lung ventilation is novel, similar studies have shown that optimizing oxygen delivery can improve outcomes in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ① General anesthesia with left bronchial tube intubation; ② Age range from 18 to 80 years old; ③ 18 kg/m2 ≤ BMI ≤ 30 kg/m2; ④ ASA grade I to III; ⑤ Individuals willing to participate in research and sign an informed consent form. Exclusion Criteria: * ① CT scan indicates preoperative pulmonary infection, atelectasis, and pneumothorax; ② History of respiratory system diseases (COPD, bronchiectasis, pulmonary alveoli, interstitial lung disease, etc.); ③ Previous history of lung surgery; ④ First second forced expiratory volume/estimated value (FEV1%)\<60%; ⑤ PaO2\<60mmhg (1 mmhg=0.133 kpa) or PaO2/FiO2\<300mmhg or SpO2\<90% in the suction state; ⑥ History of acute upper respiratory tract infection, acute lung injury, acute respiratory distress syndrome, or respiratory failure within 3 months prior to surgery; ⑦ Combined heart failure (NYHA heart function grading ≥ 3); ⑧ Previous history of stroke and cerebral infarction; ⑨ Severe liver dysfunction (liver failure or Child Pugh score B or C) Chronic renal failure (glomerular filtration rate\<30 ml/min) Suffering from mental illness, etc., which is not suitable for the author; æ Individuals who have participated in other clinical trials as subjects within the three months prior to participating in the study The patient refused to participate in the study.
Where this trial is running
Chengdu, Sichuan
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Chenghong Wang, MD
- Email: 931405180@qq.com
- Phone: 13488943096
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.