Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Fentanyl

Anesthetics

Rocuronium

Propofol

Sevoflurane

Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation

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

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.

Nonintubated 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.

Intubated thoracoscopic lobectomy

Ming-Hui Hung, MD, MSc

Jin-Shing Chen, MD, PhD

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.

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.

Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

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

Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).

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).

National Taiwan University Hospital

Wounds and Injuries

In 3D group, the investigator will intubate using DLT chosen by an automatic comparison software for 3D reconstruction based on CT data (3DRACS).

In control group, the size of DLT is based on patient's sex and weight and the height is used to guide the depth of DLT insertion.

it is an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation.

3D reconstruction automatic matching system

traditional method for selecting double lumen tube

Xin Wang, master

Yihao Zhu, master

Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients. We have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation.The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.

Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients undergoing various intra-thoracic procedures. Lung isolation is primarily accomplished with a double-lumen tube (DLT) or bronchial blocker. One published study showed that residents with limited experience had a 40% error rate in accurately placing a DLT. The accurate choice of the size of DLT is a prerequisite for good lung isolation.Currently, There is lack of proper objective criteria for selecting size of DLT. DLT size selection is estimated empirically using the patient's height and sex, and studies have shown that the size of DLT according CT images of the chest is more accurate than experience. we have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation. The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.

Participates recruited from Sichuan Cancer Hospital will randomized to 3D group and control group in 1:1 ratio via a random number list generated by a computer.

Two investigators performing intubation of DLT will be blinded to the intervention. All participates and researchers responsible for surgery, bronchoscopy assessment, follow-up, data management and analysis will also be blinded to the grouping.

3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial

Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial

Data are available on reasonable request. The raw data are available from the corresponding author with applicable reason after publishing findings to a peer-reviewed journal.

Conventional blindly endobronchial intubation is performed firstly and clinical verification was made by the same anesthesiologist, followed by the supervising anesthesiologist using a FOB to check DLT position and successful intubation was considered if the position was proper.

after completion of induction, the vocal cords are exposed using visual laryngoscopy and Cormack-Lehane grading is performed. The stopwatch is timed as soon as the cuff of DLT crosses the vocal cords and it stops when (1) intubating anesthesiologist consider the DLT is correctly positioned, (2) after a maximum of three attempts have been made, (3) the intubating anesthesiologist think DLT placed correctly is impossible. Each attempt is defined as returning the bronchial lumen of the DLT to the trachea and then attempting to reinsert it. If the DLT is unsuccessfully placed, the intubation will be performed under FOB guidance by the supervising anesthesiologist. This intubation time of supervising anesthesiologist is also counted as part of the successful intubation time.

it is a subjective score of 0-10 by the surgeon, ten mean very perfect, zero represent no pulmonary atrophy at all.

an anesthesiologist over 10 years of FOB experience will assess tracheal and vocal cord related injuries from DLT intubation. Before DLT is prepared to extubation, FOB will be inserted into the bronchial lumen and the tracheal injury will be observed through the FOB along with DLT extubated. All images from the FOB assessment are saved as a video and it will be viewed are by another blinded endoscopist to assess the injury of vocal cords. The severity of tracheal injury was defined as follows: mild (redness, oedema, one to three speckled haemorrhagic lesions), moderate (over 3 mild lesions or one diffuse haemorrhagic lesion) and severe (more than 2 diffuse haemorrhagic lesions). With regard to the vocal cords, the types of lesions are classified as follows: (1) oedema, swelling of the mucosa; (2) petechiae, small red spots on the mucosa; (3) haematoma, bleeding into the mucosa.

sore throat is defined as persistent resting pain in the throat region, and throat pain scores were assessed by VAS score (0: no pain; 10: the most unbearable pain). Hoarseness is defined as a change in the quality of voice noted by the patient.

it is defined as the area under the curve of the SpO2/FiO2 ratio during OLV. The SpO2 and FiO2 values are automatically collected by the monitor at 30 second intervals and any abnormal data due to equipment or human error will be replaced with the previous correct data.

it was defined that FOB was inserted into the tracheal tube and then withdrawn from the tracheal tube from induction to extubation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection	NCT03471884	Non-small Cell ... Lung Function D... Tracheal Intuba...	Nonintubated th... Intubated thora...	20 Years - 99 Years	National Taiwan University Hospital
3D-printed Reconstruction Automated Matching System Predicts Size of Double-lumen Tube: a Prospective Double-blinded Randomized Controlled Trial	NCT05899270	Lung Cancer Lung Diseases Tracheal Intuba... Throat Injury Bronchus; Injur...	3D reconstructi... traditional met...	18 Years - 75 Years	Sichuan Cancer Hospital and Research Institute

Spots Global Cancer Trial Database for tracheal intubation morbidity