Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

NCT ID: NCT03471884

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nonintubated thoracoscopic lobectomy

Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation

Group Type: EXPERIMENTAL

Nonintubated thoracoscopic lobectomy

Intervention Type: PROCEDURE

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.

Intubated thoracoscopic lobectomy

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

Group Type: ACTIVE_COMPARATOR

Intubated thoracoscopic lobectomy

Intervention Type: PROCEDURE

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.

Interventions

Nonintubated 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.

Intervention Type: PROCEDURE

Intubated 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Hui Hung, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Hui Hung, MD, MSc

Role: CONTACT

hung.minghui@gmail.com

02-23123456 ext. 62158

Jin-Shing Chen, MD, PhD

Role: CONTACT

chenjs@ntu.edu.tw

02-23123456 ext. 65178

Facility Contacts

Ming-Hui Hung, MD, MSc

Role: primary

hung.minghui@gmail.com

02-23123456 ext. 62158

Other Identifiers

201711003RINB

Identifier Type: -

Identifier Source: org_study_id