Comparison of double-lumen endobronchial tube and a combination of LMA ProSeal and bronchial blocker for video assisted thoracoscopic surgery

JRCT ID: jRCT1042200060

Registered date:13/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung tumor
• Date of first enrollment: 18/11/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Group A: Airway management with LMA ProSeal and bronchial blocker
Group B: Airway management using a double lumen endobronchial tube

Outcome(s)

• Primary Outcome: Incidence of hoarseness on postoperative days 1, 2, and 3

Secondary Outcome

Incidence of hoarseness and sore throat at the time of PACU exit
Incidence of sore throats on postoperative days 1, 2, and 3
Degree of sore throat with VAS on postoperative day 1
Time to complete lung collapse
Quality of surgical field and lung collapse
Time to secure the airway
Incidence of intraoperative respiratory management problems (e.g., surgical interruptions, hypoxemia, hypercapnia, unintentional pulmonary inflation, and ventilatory difficulty)
Incidence of pneumonia, air leaks from the thoracic draine, unexpected ICU admission, airway injuries (bleeding or damage to the teeth, oral cavity, vocal cords, trachea, and bronchi), number of days of thoracic drain insertion, and other perioperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

(1) Patients undergoing thoracoscopic lung surgery (including robotic-assisted surgery) for clinical stage I lung cancer under general anesthesia
(2) ASA PS (American Society of Anesthesiologists Physical Status) 1 to 3
(3) Patients for whom written consent has been obtained from the individual

Exclude criteria

(1) Patients undergoing emergency surgery
(2) Patients after tracheotomy
(3) Patients who are intubated preoperatively
(4) Patients with a history of intrathoracic surgery on the operative side
(5) Patients with a history of intrathoracic lesions on the operative side and expected adhesions
(6) Patients with anticipated tumor invasion of the bronchial tubes or vessels.
(7) Patients with an anatomical abnormality that makes normal isolated lung ventilation difficult, such as a tracheal bronchus
(8) Patients who undergo a procedure that cannot be managed with normal isolated lung ventilation, such as surgery on the left and right main bronchus.
(9) Patients who are expected to have difficulty in securing their airway
(10) Patiwnts with severe obstructive ventilatory disturbance (1-second rate <50%)
(11) Patients who are allergic to the drug to be used
(12) Patients with obvious hoarseness or sore throat preoperatively
(13) Patients who are expected to have difficulty in postoperative communication due to dementia, sequelae of cerebrovascular disease, etc.
(14) Patients who are judged by the research group to be inappropriate

Related Information

• Primary Sponsor: Nakanishi Toshiyuki