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Nov. 13, 2020

Feb. 22, 2024

jRCT1042200060

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

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

June. 30, 2022

100

pLMA+BB group (patients with a combination of the LMA ProSeal and a bronchial blocker): 49 cases DLT group (patients with a double-lumen endobroncheal tube): 49 cases Age: pLMA+BB group 67+/-11 y, DLT group 64+/-13 y Sex (Female): pLMA+BB group 23 cases, DLT gropu 24 cases Height: pLMA+BB group 161+/-9 cm, DLT group 162+/-9 cm Weight: pLMA+BB group 59+/-14 kg, DLT group 60+/-11 kg

Randomized: 100 cases (51 cases in the pLMA+BB group and 49 cases in the DLT group) Lost to follow up: 2 cases (pLMA+BB group) Analyzed: 98 patients (49 cases in the pLMA+BB group and 49 cases in the DLT group)

None

The incidences of hoarseness in the pLMA+BB and DLT groups were 42.9% and 53.1% (difference, -10.2%; 95% confidence interval, -30.1% to 10.3%; p =0.419), 18.4% vs. 32.7%, and 20.4% vs. 24.5% on postoperative day 1, 2, and 3, respectively. The incidences of sore throat in the pLMA+BB and DLT groups were 16.3% vs. 34.7% (difference, -18.4%; 95% confidence interval, -35.9% to -0.9%; p=0.063) on postoperative day 1. In the pLMA+BB group, more intraoperative complications and less coughing during emergence were observed compared to the DLT group. Lung collapse and placement-related outcomes were comparable between the groups.

The combination of ProSeal laryngeal mask airway and bronchial blocker did not significantly reduce hoarseness compared to the double-lumen endobronchial tube.

May. 01, 2023

May. 01, 2023

https://doi.org/10.1016/j.jclinane.2023.111136

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT1042200060

Nakanishi Toshiyuki

Nagoya City University Hospital

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-853-8281

nakanishi.anest@gmail.com

Nakanishi Toshiyuki

Nagoya City University Hospital

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-853-8281

nakanishi.anest@gmail.com

Complete

Nov. 13, 2020

Nov. 18, 2020
100

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

(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

(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

20age old over
85age old not

Both

Lung tumor

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

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

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

Nagoya City University Certified Review Board
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-858-7215

rinshou-kenkyu@med.nagoya-cu.ac.jp
Approval

Oct. 14, 2020

none

History of Changes

No Publication date
4 Feb. 22, 2024 (this page) Changes
3 Mar. 18, 2022 Detail Changes
2 Jan. 25, 2021 Detail Changes
1 Nov. 13, 2020 Detail