Preventing lung complications after gynecologic surgery using high-flow nasal oxygen
A Randomized Controlled Trial on the Preventive Effect of Heated Humidified High Flow Nasal Cannula Oxygen Therapy on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
This study is testing if high-flow nasal oxygen can help prevent lung problems after gynecologic surgery in patients who are at high risk for these issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Sichuan Cancer Hospital and Research Institute Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT05526534 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of high-flow nasal cannula (HFNC) oxygen therapy in preventing postoperative pulmonary complications in patients undergoing gynecologic surgery. Patients at high risk for these complications will be randomly assigned to receive either HFNC or conventional nasal cannula oxygen therapy. The primary outcome measured will be the incidence of postoperative pulmonary complications such as hypoxemia, atelectasis, and pneumonia, while secondary outcomes will include improvements in oxygenation, antibiotic use, length of hospital stay, and any adverse events related to the oxygen therapy. The study will enroll patients aged 18 to 90 with specific respiratory risk factors.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 90 with gynecologic neoplasms who are at high risk for postoperative pulmonary complications.
Not a fit: Patients with lung metastasis, previous lung surgery, or those undergoing segmental bowel resection 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 high-risk patients undergoing gynecologic surgery.
How similar studies have performed: Other studies have shown promising results with high-flow nasal cannula therapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with gynecologic Neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest CT scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met: 1. Assess respiratory risk in surgical patients in Catalonia (ARRSPC) ≥45 points; 2. BMI≥30; 3. Moderate to severe asthma; 4. Moderate to severe chronic obstructive pulmonary disease (COPD); 5. Smoking history ≥20 packs/year Exclusion Criteria: 1. Patients with lung metastasis of malignant tumor or primary lung malignant tumor; 2. previous lung surgery or radiotherapy; 3. the surgery involved segmental bowel resection.
Where this trial is running
Chengdu, Sichuan
- Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Dengfeng Wang, M.D. — Sichuan Cancer Hospital and Research Institute
- Study coordinator: Dengfeng Wang, M.D.
- Email: wonderful_96@163.com
- Phone: +86 159 82222707
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.