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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042200060
Enrollment
100
Registered
2020-11-13
Start date
2020-11-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung tumor

Interventions

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

Sponsors

Nakanishi Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence of hoarseness on postoperative days 1, 2, and 3

Secondary

MeasureTime frame
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

Contacts

Public ContactToshiyuki Nakanishi

Nagoya City University Hospital

nakanishi.anest@gmail.com+81-52-853-8281

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026