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

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult
• Intervention / Treatment: Device: Fibreoptic intubation with silicone double lumen tube; Device: Fibreoptic intubation with PVC double lumen tube

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou universiry hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: silicone DLT; Fibreoptic intubation with silicone double lumen tube	Device: Fibreoptic intubation with silicone double lumen tube; Fibreoptic intubation with silicone double lumen tube
EXPERIMENTAL: PVC DLT; Fibreoptic intubation with PVC double lumen tube	Device: Fibreoptic intubation with PVC double lumen tube; Fibreoptic intubation with PVC double lumen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
railroading grade	grade of ease of railroading over fibreoptic bronchoscope.; no difficulty passing the tube; obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2); obstruction necessitating more than one manipulation or external laryngeal manipulation; direct laryngoscope was required	an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time	time from insertion of FOB into mouth to tube placement into trachea and left main bronchus	an average of 2 minutes
number of patients with trauma around glottis, observed by FOB	glottic trauma observation through FOB outside the tube	an average of 2minutes
number of patients with tube repositioning during the surgery	count of tube repositioning with FOB during the surgery	an average of 3.5 hours
number of patients with complication of hoarseness, sore throat, and swallowing difficulty	hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit	an average of 30 minutes

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Dae Hee Kim, M.D., Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2019
• Primary Completion (ACTUAL): December 19, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: double lumen tube; Fiberoptic intubation
• Other Study ID Numbers: AJIRB-DEV-THE-18-44-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No