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

NCT03889847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-01-20

No results posted yet for this study

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

  • Intubation;Difficult

Interventions

DEVICE

Fibreoptic intubation with silicone double lumen tube

Fibreoptic intubation with silicone double lumen tube

DEVICE

Fibreoptic intubation with PVC double lumen tube

Fibreoptic intubation with PVC double lumen tube

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Dae Hee Kim, M.D. · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2019-12-19
Completion
2019-12-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889847 on ClinicalTrials.gov