NCT03782090

Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation

Completed NA Last updated 20 May 2019

What this trial tests

NA trial testing Endobronchial intubation in Intubation Tube(Intubation Using Double Lumen Endobronchial Tube) in 190 participants. Completed in 31 January 2019.

Timeline

5 September 2018

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	190
Start date	5 September 2018
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Endobronchial intubation

Conditions studied

• Intubation Tube(Intubation Using Double Lumen Endobronchial Tube) — all drugs for Intubation Tube(Intubation Using Double Lumen Endobronchial Tube) →

Sponsor

Yonsei University

Who can join

Adults 20 to 85, any sex, with Intubation Tube(Intubation Using Double Lumen Endobronchial Tube). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial Comparing Novel Triple-Cuffed Double-Lumen Endobronchial Tubes with Conventional Double-Lumen Endobronchial Tubes for Lung Isolation.
   Kim N, Byon HJ, Kim GE, Park C, et al · · 2020 · cited 9× · PMID 32244659 · DOI 10.3390/jcm9040977