Neoplasms

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Head and Neck Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

Laryngoscopy

Tracheal Intubation

Carin Hagberg

Carin A. Hagberg

This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in patients with head and neck cancer before surgery. Flexible intubation scope and video laryngoscope are devices that have a small camera to help the doctor see the patient's airway on a screen. Both devices may help the doctor who gives anesthesia prevent complications from placing the breathing tube (such as pain or mouth injury).

PRIMARY OBJECTIVES:

I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management.

SECONDARY OBJECTIVES:

I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of the video laryngoscope (VL).

II. Total time for securing the airway.

III. Number of attempts required for intubation.

IV. Rate of failure at intubation.

V. Incidence of desaturation.

VI. Assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery

Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial

Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.

For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Platelet Aggregation Inhibitors

Bupivacaine

Rocuronium

Propofol

Sevoflurane

Anesthetics, Local

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Patients undergoing thoracoscopic surgery using nonintubated technique with propofol and bupivacaine.

Patients undergoing thoracoscopic surgery using intubated general anesthesia with sevoflurane and rocuronium.

Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.

propofol, bupivacaine

Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.

sevoflurane, rocuronium

Ming-Hui Hung, MD, MSc

Ya-Jung Cheng, MD, PhD

Jin-Shing Chen, MD, PhD

Lung cancer is the leading cause of cancer death in Taiwan and worldwide. With the advancement of thoracoscopic technique, thoracoscopic surgery has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC). Additionally, current lung cancer screening policy recruits increasing number of candidates requiring thoracoscopic lung resections because of lung nodules/tumors. Traditionally, intubated general anesthesia with one-lung ventilation using a double-lumen endotracheal tube or an endobronchial blocker has been considered mandatory in thoracoscopic surgery. However, adverse effects of intubated general anesthesia are not negligible. Recently, a nonintubated thoracoscopic technique has developed to reduce the adverse effects of intubated general anesthesia with encouraging results. Nonetheless, the role of nonintubated technique in thoracoscopic lung resection surgery in quality of postoperative recovery in not clear. As an enhanced recovery is the major goal of modern minimally invasive surgery, the investigators hypothesize that nonintubated thoracoscopic technique can facilitate and improve the recovery quality after surgery. To this end, the investigators will recruit 300 patients in subgroups including patients undergoing segmentectomy/lobectomy, wedge resection and geriatric patients in this two-year project. Patients will be randomly allocated in nonintubated and intubated groups and quality of recovery of all patients will be evaluated according the protocol of Postoperative Quality of Recovery Scale. In the meantime, the preoperative and postoperative cytokines will be compared between the groups as well as patients with different recovery scales.

Treatment protocol of nonintubated technique and intubated general anesthesia

Nonintubated technique: All nonintubated patients will be premedicated with 50 to 100 μg of fentanyl intravenously and will be continuously monitored electrocardiographically, along with pulse oximetry, respiratory rate, blood pressure, body temperature, and urine output. End-tidal carbon dioxide will be continuously monitored by insertion of a detector into one nostril. A bispectral index sensor (BIS Quatro, Aspect Medical System, Norwood, MA, USA) will be applied to the forehead of each patient to monitor the level of consciousness. Additionally, a non-invasive near-infrared cerebral regional oximetry (INVOSTM 5100BINVOS 5100B Cerebral Oximeter, Somanetics Corporation, Troy, MI, USA) will be applied to monitor the regional oxygen saturation of the brains. The patients will be sedated with intravenous propofol (Fresol 1%, Fresenius Kabi GmbH, Graz, Austria) using a target-controlled infusion method (Injectomat® TIVA Agilia, Fresenius Kabi GmbH, Graz, Austria). The level of sedation will be set to achieve a bispectral index value between 40 and 60, and incremental intravenous injections of fentanyl 25 μg will be given to maintain a respiratory rate between 12 and 20 breaths/min. Oxygen will be supplied through a ventilation mask.

Conventional intubated general anesthesia: All intubated patients will be monitored as for nonintubated patients. Anesthesia will be induced by intravenous administration of propofol (1 - 2.5 mg/kg), fentanyl (100 μg), and rocuronium (0.6 mg/kg) and will be maintained by sevoflurane and rocuronium at the discretion of anesthesiologist and bispectral index monitoring. A double-lumen endotracheal tube or endobronchial blocker will be inserted for one lung isolation during the procedure and a bronchoscopy will be used to facilitate the correct isolation of targeted bronchus at the discretion of anesthesiologist. The dependent lung will be ventilated using protective lung strategy with a tidal volume of 6 to 8 mL/kg, a respiratory rate of 10 to 16 breaths/min to maintain the arterial carbon dioxide tension at 35 to 45 mmHg. After the operation, the patients will be extubated in the operating room or remain intubated and be sent to the intensive care unit at the discretion of anesthesiologist.

Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection

Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection: A Prospective Randomized Trial

PQRS is a measure tool to evaluate the patient recovery after surgery, which includes five domains, i.e., physiological factors, nociceptive factors, emotional factors, recovery of activity of daily life and cognitive factors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery	NCT03757091	Head and Neck N...	Laryngoscopy Tracheal Intuba...	18 Years -	M.D. Anderson Cancer Center
Effects of Nonintubated Versus Intubated General Anesthesia on Recovery After Thoracoscopic Lung Resection	NCT02393664	Lung Neoplasms	propofol, bupiv... sevoflurane, ro...	20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for tracheal intubation