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

A

Ajou University School of Medicine

Status

Completed

Conditions

Intubation;Difficult

Treatments

Device: Fibreoptic intubation with silicone double lumen tube
Device: Fibreoptic intubation with PVC double lumen tube

Study type

Interventional

Funder types

Other

Identifiers

NCT03889847
AJIRB-DEV-THE-18-44-

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2

Exclusion criteria

  • abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

silicone DLT
Experimental group
Description:
Fibreoptic intubation with silicone double lumen tube
Treatment:
Device: Fibreoptic intubation with silicone double lumen tube
PVC DLT
Experimental group
Description:
Fibreoptic intubation with PVC double lumen tube
Treatment:
Device: Fibreoptic intubation with PVC double lumen tube

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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