Clinical trial NCT03471884: Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection
Official title: Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lung Function Decreased
Tracheal Intubation Morbidity
Keywords: Thoracoscopic surgery,Airway Management,Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lung function assessment
timeFrame: 12 hours
Secondary outcomes:
measure: Oxidative and systemic inflammatory cytokines.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Hui Hung, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: