Effects of oxygen levels on lung complications after esophageal cancer surgery
Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer
This study tests if using lower oxygen levels during breathing support can help patients having esophageal cancer surgery avoid lung problems after their operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China Medical University, China Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06013098 on ClinicalTrials.gov |
What this trial studies
This study investigates how different concentrations of oxygen during mechanical ventilation affect the occurrence of pulmonary complications in patients undergoing radical resection of esophageal cancer. It aims to determine whether using lower oxygen concentrations (30%) compared to standard levels (60%) can maintain adequate oxygen saturation while reducing postoperative complications. The study will involve patients with specific health conditions scheduled for elective surgery, and it will monitor their postoperative outcomes related to lung health. The findings could provide insights into optimal ventilation strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with ASA physical status I-II scheduled for elective esophageal cancer surgery with adequate preoperative oxygen levels.
Not a fit: Patients with a history of acute lung injury, severe heart failure, significant liver or kidney dysfunction, high body mass index, coagulation disorders, or those undergoing prolonged surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced pulmonary complications for patients undergoing esophageal cancer surgery.
How similar studies have performed: While there is limited research specifically on oxygen concentrations in this context, the study builds on established principles of lung protective ventilation strategies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Association of Anesthesiologists (ASA) patients with I-II physical condition; * Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position. Exclusion Criteria: * there is a history of acute lung injury with acute respiratory distress syndrome within three months; * Heart failure (classified by new york Heart Association) is greater than grade IV, * there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate \< 30 ml/min); * Body mass index \> 30kg/m2； * coagulation dysfunction; * Operation time exceeds 10h * The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.
Where this trial is running
Shenyang, Liaoning
- the First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
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.