Clinical Trials Directory

Trials / Completed

CompletedNCT03392766

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

Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Ajou University School of Medicine · Academic / Other
Sex
All
Age
19 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEsingle lumen tube and bronchial blockerneck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
DEVICEdouble lumen tubeneck collar apply. fibreoptic intubation with double lumen tube.

Timeline

Start date
2018-02-09
Primary completion
2019-04-22
Completion
2019-04-22
First posted
2018-01-08
Last updated
2019-04-23

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03392766. Inclusion in this directory is not an endorsement.