Lung Function Decreased, Non-small Cell Lung Cancer, Tracheal Intubation Morbidity
Conditions
Keywords
Thoracoscopic surgery,Airway Management,Anesthesia
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.
Interventions
PROCEDURENonintubated thoracoscopic lobectomy
Nonintubated general anesthesia using fentanyl, target-controlled infusion of propofol to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a spontaneous breathing due to iatrogenic pneumothorax.
PROCEDUREIntubated thoracoscopic lobectomy
Intubated general anesthesia using 2%-3% sevoflurane and rocuronium to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a endobronchial tube or blocker with use of mechanical ventilation.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* adults (\> 20 year-old), lung cancer patients undergoing thoracoscopic lobectomy
Exclusion criteria
* obesity (BMI \> 26 kg/m2) * previous ipsilateral thoracic surgery * severe ventilatory insufficiency (oxygen/BiPAP user) * poor cardiopulmonary function (preop forced expiratory volume at one second (FEV1) \<60%, preop left ventricular ejection fraction \< 50%) * autoimmune disease requiring chronic steroids * patients with difficult airway management, pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung function assessment | 12 hours | Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Taiwan
Contacts
Primary ContactMing-Hui Hung, MD, MSc
Backup ContactJin-Shing Chen, MD, PhD
Outcome results
None listed