Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection
- Conditions
- Lung Function DecreasedTracheal Intubation MorbidityNon-small Cell Lung Cancer
- Interventions
- Procedure: Nonintubated thoracoscopic lobectomyProcedure: Intubated thoracoscopic lobectomy
- Registration Number
- NCT03471884
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
A novel nonintubated thoracoscopic technique is promising to enhance recovery after thoracic surgery. However, the effects of nonintubated technique on specific organ protection in not clear yet. In this randomized trial, the effect of nonintubated technique on lung function protection will be evaluated via PaO2/FiO2 ratio, oxidative stress and inflammatory cytokines serially in lung cancer patients undergoing thoracoscopic lobectomy.
- Detailed Description
Lung cancer is the leading cause of cancer-related death worldwide. Its incidence is increasingly arising recently. For early-stage non-small cell lung cancer, surgery is the standard treatment that offers best chance of survival. For thoracoscopic lung cancer surgery, tracheal intubation with one-lung ventilation is regarded the standard anesthetic management to establish a safe operating environment. However, complications associated with intubated general anesthesia are not negligible. A novel nonintubated thoracoscopic technique is developing and applied in a variety of thoracic diseases. A previous study showed that nonintubated thoracoscopic lobectomy was feasible and safe in lung cancer patients. Furthermore, nonintubated techniques was also associated with a faster recovery of oral intake, less postoperative complications and shorter hospital stay. The effects of nonintubated thoracoscopic technique on specific organ protection is not clear yet.
The aim of this investigation is to explore the effects of nonintubated thoracoscopic lobectomy on lung function protection in lung cancer patients, comparing with the standard intubated patients as a control. The investigators are going to enrol 82 lung cancer patients and randomize them equally to complete thoracoscopic lobectomy with lymphadenectomy either with a nonintubated technique (n=41) or an intubated technique (n=41). The assessment of lung function will be obtained from serial blood gas analyses using PaO2/FiO2 ratio. Additionally, oxidative stress and inflammatory cytokines will be measured from serial blood samples including 8-isoprostane, malondialdehyde, tumor necrosis factor-α, interleukin-6, interleukin-10, S100-β and neuron specific enolase.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nonintubated thoracoscopic lobectomy Nonintubated thoracoscopic lobectomy Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation Intubated thoracoscopic lobectomy Intubated thoracoscopic lobectomy Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation
- Primary Outcome Measures
Name Time Method Lung function assessment 12 hours Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).
- Secondary Outcome Measures
Name Time Method Oxidative and systemic inflammatory cytokines. 24 hours Oxidative and systemic inflammatory cytokines will be measured from serial blood samples, including 8-isoprostane (pg/mL), malondialdehyde (nM), tumor necrosis factor-alpha (pg/mL), interleukin-6 (pg/mL), interleukin-10 (pg/mL), S100-beta (pg/mL), and neuron specific enolase (ng/mL).
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan