Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

National Taiwan University

Status: Unknown

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

Treatments: Procedure: Intubated thoracoscopic lobectomy; Procedure: Nonintubated thoracoscopic lobectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03471884

201711003RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Nonintubated thoracoscopic lobectomy

Experimental group

Description:

Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation

Treatment:

Procedure: Nonintubated thoracoscopic lobectomy

Intubated thoracoscopic lobectomy

Active Comparator group

Description:

Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation

Treatment:

Procedure: Intubated thoracoscopic lobectomy