Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03471884
• Other study ID #: 201711003RINB
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 19, 2018
• Start date: March 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: National Taiwan University Hospital
• Contact: Ming-Hui Hung, MD, MSc
• Phone: 02-23123456
• Email: hung.minghui[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Function Decreased
• Non-small Cell Lung Cancer
• Tracheal Intubation Morbidity

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function assessment	Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).	12 hours
Secondary	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