Randomized Study of Heated Humidified High Flow Nasal Cannula Oxygen to Prevent Lung Complications After Gynecologic Tumor Surgery
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2025-05-23
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of heated humidified high flow nasal cannula HFNC oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications PPC. The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy.
Participants are randomly assigned to one of two groups the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37C and a maximum flow of 70 liters per minute.
During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.
CONDITIONS
Brief Title
A RCT on the Preventive Effect of HFNC on Postoperative Pulmonary Complications in Patients With Gynecologic Neoplasms
Research Team
D
Dengfeng Wang, M.D.
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Diagnosis of gynecologic neoplasms (benign or malignant) scheduled for surgery at the study center
Surgery expected to last 2 hours or longer
Must have a chest CT scan within 1 week before surgery
Must meet at least one of the following: respiratory risk score ≥45, BMI ≥30, moderate to severe asthma, moderate to severe COPD, or smoking history of 20 or more pack-years
You will not qualify if you...
Presence of lung metastasis from malignant tumor or primary lung cancer
Previous lung surgery or lung radiotherapy
Surgery involving segmental bowel resection
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 2 days
Participants undergo gynecologic surgery and receive oxygen therapy via either heated humidified high flow nasal cannula or conventional nasal cannula on the day of surgery and the first day after surgery to maintain oxygen saturation between 92% and 95%.
1 surgery day visit and 1 post-operative day visit
Post-operative Follow-up
Duration - 7 days
Participants have chest CT reviewed 36 to 48 hours after surgery and are monitored for postoperative pulmonary complications, oxygenation, antibiotic use, and adverse events related to oxygen therapy up to 7 days after surgery.
1 follow-up visit within 7 days after surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA).
Emmanuel Futier, Catherine Paugam-Burtz, Thomas Godet...