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Clinical Trials/NCT03889847
NCT03889847
Completed
Not Applicable

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

Ajou University School of Medicine1 site in 1 country46 target enrollmentApril 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation;Difficult
Sponsor
Ajou University School of Medicine
Enrollment
46
Locations
1
Primary Endpoint
railroading grade
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 25, 2019
End Date
December 20, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ajou University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

DAE HEE KIM

Associate professor

Ajou University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

railroading grade

Time Frame: an average of 2 minutes

grade of ease of railroading over fibreoptic bronchoscope. 1. no difficulty passing the tube 2. obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2) 3. obstruction necessitating more than one manipulation or external laryngeal manipulation 4. direct laryngoscope was required

Secondary Outcomes

  • insertion time(an average of 2 minutes)
  • number of patients with complication of hoarseness, sore throat, and swallowing difficulty(an average of 30 minutes)
  • number of patients with trauma around glottis, observed by FOB(an average of 2minutes)
  • number of patients with tube repositioning during the surgery(an average of 3.5 hours)

Study Sites (1)

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