Tubeless anesthesia to prevent lung complications during early-stage lung cancer surgery
Tubeless Anesthesia in Preventing Contralateral Lung Complications in Patients Undergoing Single-Port Thoracoscopic Surgery for Early-Stage Lung Cancer: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
This trial will test whether tubeless anesthesia (avoiding tracheal intubation) reduces lung complications and speeds recovery for adults having single-port thoracoscopic surgery for early-stage lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07024433 on ClinicalTrials.gov |
What this trial studies
The trial compares tubeless anesthesia, which preserves spontaneous breathing without tracheal intubation, to traditional tracheal intubation in patients undergoing single-port thoracoscopic resection for early-stage lung cancer. Eligible adults (ECOG 0–1) with good cardiac and pulmonary function and peripheral lung nodules will be enrolled, while patients with obesity, difficult airways, heavy secretions, severe hypoxia/hypercapnia, or expected extensive pleural adhesions are excluded. Primary outcomes include contralateral lung complications, perioperative hemodynamics, complication rates, and recovery speed, with additional monitoring for safety and need to convert to intubation. The study collects intraoperative and postoperative data to compare feasibility, safety, and clinical recovery between the two anesthesia approaches.
Who should consider this trial
Good fit: Adults 18–70 with early-stage peripheral lung nodules planned for single-port thoracoscopic surgery, ECOG 0–1, and good cardiac and pulmonary function are ideal candidates.
Not a fit: Patients with BMI >30, difficult or complex airways, copious airway secretions, severe hypoxia or hypercapnia, extensive pleural adhesions, prior induction chemoradiotherapy, or inability to cooperate while awake are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, tubeless anesthesia could reduce postoperative lung injury and intubation-related harms while shortening recovery after minimally invasive lung cancer surgery.
How similar studies have performed: Smaller pilot and observational studies suggest tubeless anesthesia can be safe and may reduce some pulmonary complications in selected thoracoscopic cases, but randomized comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years and ≤70 years; 2. ECOG performance status score 0-1; 3. Good cardiac and pulmonary function; 4. Single or multiple peripheral lung nodules planned for single-port thoracoscopic surgery, with or without mediastinal lymph node dissection or sampling; 5. Able to comply with the study visit schedule and other protocol requirements; 6. Signed informed consent and voluntary participation in the study. Exclusion Criteria: 1. Obese patients (BMI \>30); 2. Patients with difficult intubation or expected complex airway management; 3. COPD patients with copious airway secretions; 4. Patients with neurological dysfunction or who cannot cooperate while awake; 5. Patients expected to have extensive pleural adhesions or with previous lung resection; 6. Elderly and frail patients with severe hypoxia (PaO2 \<60 mmHg) or hypercapnia (PaCO2 \>50/55 mmHg); 7. Previous induction chemotherapy or chemoradiotherapy; 8. Intraoperative need to isolate the lung to prevent spillage and contamination of the contralateral lung; 9. Patients expected to have large surgical wounds and lengthy procedures, clinically assessed as unsuitable; 10. Patients whose cardiac and pulmonary function, or overall health, cannot withstand the procedure.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Shishi Huang
- Email: twolions1997@163.com
- Phone: +81 18120825212
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.