Clinical Trials Directory

Trials / Completed

CompletedNCT03889847

Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

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

Summary

One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. 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 easier than the Shilly tube. In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.

Conditions

Interventions

TypeNameDescription
DEVICEFibreoptic intubation with silicone double lumen tubeFibreoptic intubation with silicone double lumen tube
DEVICEFibreoptic intubation with PVC double lumen tubeFibreoptic intubation with PVC double lumen tube

Timeline

Start date
2019-04-25
Primary completion
2019-12-19
Completion
2019-12-20
First posted
2019-03-26
Last updated
2021-01-20

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03889847. Inclusion in this directory is not an endorsement.