Clinical Trial: Feasibility of non-intubated ("tubeless") anesthesia for video-assisted thoracoscopic surgery in a single Japanese institution: a prospective observational study (Japan)

Tokyo, Sept. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062884) titled 'Feasibility of non-intubated ("tubeless") anesthesia for video-assisted thoracoscopic surgery in a single Japanese institution: a prospective observational study' on Sept. 12.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokyo Metropolitan Bokutoh Hospital

Condition: Condition - Primary lung cancer, metastatic lung tumor, pneumothorax and other diseases requiring thoracic surgery Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - In thoracic surgery, conventional management with endotracheal intubation and one-lung ventilation under positive-pressure ventilation is associated with ventilation-induced lung and airway injury, as well as delayed postoperative recovery related to deep sedation and muscle relaxants. Recently, the combination of "tubeless anesthesia" -preserving spontaneous breathing without endotracheal intubation- with uniportal video-assisted thoracoscopic surgery (Uniportal VATS) has been spreading overseas, but it has not yet become widespread in Japan. The aim of this study is to develop a protocol for tubeless thoracic surgery/anesthesia suited to the Japanese setting and to verify its feasibility as a prospective observational study. Through iterative refinement of the protocol, we aim to contribute to the early recovery of a greater number of patients. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Tubeless anesthesia (an anesthetic management technique preserving spontaneous breathing without endotracheal intubation) is used to perform uniportal video-assisted thoracoscopic surgery (Uniportal VATS). Perioperative management is conducted according to a standardized protocol adapted for the Japanese setting, and the protocol completion rate and safety are evaluated.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients undergoing partial lung resection by uniportal video-assisted thoracoscopic surgery (Uniportal VATS) with an ASA-PS classification of 3 or lower. Target conditions are early-stage lung cancer or pneumothorax requiring surgical treatment. Key exclusion criteria - Emergency surgery cases; cases in which major bleeding or prolonged surgery is anticipated; BMI > 30; cases in which a difficult airway is anticipated; patients at high risk of upper gastrointestinal reflux (post-esophagectomy, post-total gastrectomy, or cases in which fasting cannot be reliably maintained); cases in which airway management with a supraglottic device carries risk (e.g., asthma, infection); cases with suspected allergy to the drugs used; cases with elevated intracranial pressure; cases at high risk of hemodynamic instability due to cardiac disease or other conditions; cases with coagulation abnormalities; and other cases judged by the surgeon and anesthesiologist to be appropriate for exclusion. Target Size - 10

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 03 Month 01 Day Date of IRB - 2025 Year 01 Month 29 Day Anticipated trial start date - 2025 Year 04 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071019

Disclaimer: Curated by HT Syndication.