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

Ajou University School of Medicine

Status: Completed

Conditions: Intubation;Difficult; Thoracic Diseases

Treatments: Device: double lumen tube; Device: single lumen tube and bronchial blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT03392766

AJIRB-DEV-OBS-17-247

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2

Exclusion criteria

• abnormality of upper airway gastroesophageal disease risk of aspiration BMI > 35

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Single lumen tube and bronchial blocker

Experimental group

Description:

neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker

Treatment:

Device: single lumen tube and bronchial blocker

Double lumen tube

Experimental group

Description:

neck collar apply. fibreoptic intubation with double lumen tube

Treatment:

Device: double lumen tube