Actively Recruiting
Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications
Led by Sichuan Provincial People's Hospital · Updated on 2024-10-31
156
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer is with the highest incidence rate and mortality among people over 60 years old in China. Postoperative pulmonary complications (PPCs) is the most common complication after pneumonectomy, which has a significant impact on the short-term and long-term prognosis of patients, and is even the primary risk factor leading to early postoperative death. High fraction of inspired oxygen (FiO2) is an independent risk factor for PPCs, but it is difficult to achieve oxygenation while avoiding hyperxemia during one lung ventilation (OLV). We will randomly divide patients who plan to undergo thoracoscopic pulmonary resection into two groups. During OLV, titration will be used to determine the optimal FiO2 for titration group while FiO2 of 80% will be used for mechanical ventilation for control group. The incidence of postoperative PPCs, hypoxia/hyperxemia, severity level of postoperative PPC, postoperative 30 day PPC, increased hospitalization costs, and prolonged hospital stay will be observed in both groups of patients.We will evaluate the effectiveness and safety of titrating inhaled oxygen concentration in lung protection during OLV.
CONDITIONS
Official Title
Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Body mass index (BMI) between 18 and 30 kg/m2
- Scheduled for general anesthesia with left bronchial tube intubation
- ASA physical status grade I to III
- Willing to participate and able to provide informed consent
You will not qualify if you...
- Preoperative CT scan showing pulmonary infection, atelectasis, or pneumothorax
- History of respiratory diseases such as COPD, bronchiectasis, pulmonary alveoli disease, or interstitial lung disease
- Previous lung surgery
- Forced expiratory volume in 1 second (FEV1%) less than 60%
- Low oxygen levels before surgery (PaO2 < 60 mmHg, SpO2 < 90%, or PaO2/FiO2 < 300 mmHg)
- Acute respiratory infections or lung injury within 3 months before surgery
- Heart failure with NYHA class 3 or higher
- History of stroke or cerebral infarction
- Severe liver dysfunction or advanced chronic kidney disease
- Mental illness affecting participation
- Participation in another clinical trial within the past 3 months
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 641400
Actively Recruiting
Research Team
C
Chenghong Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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