This is a prospective, single-center, non-inferiority randomized controlled trial designed to evaluate the perioperative safety and feasibility of non-intubated spontaneous ventilation anesthesia (NIV) compared to conventional intubated mechanical ventilation anesthesia (IMV) in patients undergoing thoracoscopic esophagectomy for esophageal cancer. The study will be conducted at the First Affiliated Hospital of Guangzhou Medical University and aims to assess whether the non-intubated approach can offer comparable or better outcomes in terms of intraoperative and postoperative complications, anesthetic drug consumption, recovery parameters, and overall postoperative rehabilitation.
Eligible patients aged 18 to 75 years with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (stage I-III) will be randomly assigned (1:1) to receive either NIV using a laryngeal mask airway or IMV with a double-lumen endotracheal tube. Both groups will undergo the same thoracoscopic and laparoscopic surgical procedures, and anesthesia will be managed with standardized protocols. The primary outcome is the incidence of intraoperative and postoperative complications, including hypoxemia, hypercapnia, respiratory failure, and the need for conversion to intubation. Secondary outcomes include anesthetic drug dosage, intraoperative hemodynamic stability, postoperative pain scores, time to ambulation, length of hospital stay, and 30-day readmission rate.
This trial complies with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
Age between 18 and 75 years
Diagnosed with resectable middle or lower thoracic esophageal squamous cell carcinoma or adenocarcinoma (clinical stage I-III)
Scheduled to undergo thoracoscopic esophagectomy
American Society of Anesthesiologists (ASA) score ≤ III
Severe risk of aspiration due to reflux, gastric retention, or hiatal hernia
Body mass index (BMI) ≥ 30 kg/m²
Extensive pleural adhesions discovered preoperatively
History of upper thoracic or intrathoracic surgery
Parallel
Non-intubated spontaneous ventilation anesthesia
Procedure/SurgeryNon-intubated spontaneous ventilation anesthesia
Incidence of intraoperative and postoperative complications
Composite incidence of complications occurring intraoperatively or within 30 days after surgery, including hypoxemia (SpO₂ \< 90% for \>1 minute), hypercapnia (PaCO₂ ≥ 65 mmHg), conversion to intubation (in the non-intubated group), severe arrhythmia, hemodynamic instability, postoperative pulmonary infection, anastomotic leakage, bleeding, pneumothorax, respiratory failure, and reintubation.
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