Evaluating oxygen levels to reduce lung complications after thoracic surgery
Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion Following One-lung Ventilation in Thoracic Surgery（DOC-PCT Trial）- A Prospective Randomized Controlled Clinical Study.
This study tests if using higher or lower oxygen levels during lung surgeries can help patients avoid breathing problems after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06202586 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of two different oxygen concentrations, 80% and 30% FiO2, on the occurrence of postoperative pulmonary complications (PPCs) following thoracic surgeries that involve one-lung ventilation. It focuses on patients undergoing elective lung, esophageal, or mediastinal surgeries and evaluates the incidence of PPCs within the first week post-surgery. The study is designed as a randomized controlled trial to provide evidence for optimizing oxygen management during thoracic surgeries and improving patient outcomes. By comparing high and low oxygen levels, the research seeks to establish a more effective ventilation strategy that minimizes respiratory complications.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 undergoing elective thoracic surgery with one-lung ventilation and ASA grades I to III.
Not a fit: Patients with severe lung infections, recent coronary heart disease, or those requiring continuous oxygen therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for patients undergoing thoracic surgery.
How similar studies have performed: While there is evidence suggesting that lower FiO2 may be beneficial in non-thoracic surgeries, this specific approach in thoracic surgery is still being explored and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:1. Elective thoracic surgery: lung surgery, esophageal surgery, mediastinal surgery, etc.; 2. One-lung ventilation: double lumen bronchial cannula or occluder is used for isolation of one lung; 3, American Society of Anesthesiology (ASA) grade I \~ III; 4, 18 years ≤ age \< 80 years; 5. Estimated operation time ≥2 hours; 6. Agree to participate and sign the informed consent. Exclusion Criteria: 1. Severe lung infection occurs within 1 month; 2. Coronary heart disease or heart failure occurs within 2 or 3 months; 3. Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI\>35 kg/m2; 6. Pregnant women; 7. Preoperative Hb\<70g/L or haematocrit\<30%.
Where this trial is running
Shanghai, Shanghai
- Renji Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Wang Xiaojing, M.D.
- Email: yoyowxj@163.com
- Phone: +8613764152169
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.