NCT03392766

Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

Completed NA Last updated 23 April 2019

What this trial tests

NA trial testing single lumen tube and bronchial blocker in Intubation;Difficult in 80 participants. Completed in 22 April 2019.

Timeline

9 February 2018

Primary endpoint
22 April 2019

22 April 2019

Quick facts

Lead sponsor	Ajou University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	80
Start date	9 February 2018
Primary completion	22 April 2019
Estimated completion	22 April 2019
Sites	1 location across South Korea

Drugs / interventions tested

• single lumen tube and bronchial blocker
• double lumen tube

Conditions studied

• Intubation;Difficult — all drugs for Intubation;Difficult →
• Thoracic Diseases — all drugs for Thoracic Diseases →

Sponsor

Ajou University School of Medicine

Who can join

Adults 19 to 75, any sex, with Intubation;Difficult or Thoracic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.

Publications & conference data

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

1. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial.
   Kang S, Chae YJ, Kim DH, Bae SY, et al · · 2023 · cited 1× · PMID 37225777 · DOI 10.1038/s41598-023-35635-1