Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection: A Randomized Controlled Trial

Conditions
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Non-small Cell Lung Cancer, Lung Function Decreased, Tracheal Intubation Morbidity

Intervention / Treatment
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* Procedure: Nonintubated thoracoscopic lobectomy
* Procedure: Intubated thoracoscopic lobectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonintubated thoracoscopic lobectomy<br>Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation | Procedure: Nonintubated thoracoscopic lobectomy<br>* 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.<br>|
| Active Comparator: Intubated thoracoscopic lobectomy<br>Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation | Procedure: Intubated thoracoscopic lobectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function assessment | Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2). | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative and systemic inflammatory cytokines. | 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). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopic surgery,Airway Management,Anesthesia