NCT03889847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

March 18, 2019

Last Update Submit

January 17, 2021

Conditions

Intubation;Difficult

Keywords

Fiberoptic intubationdouble lumen tube

Outcome Measures

Primary Outcomes (1)

  • railroading grade

    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

    an average of 2 minutes

Secondary Outcomes (4)

  • insertion time

    an average of 2 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

  • number of patients with complication of hoarseness, sore throat, and swallowing difficulty

    an average of 30 minutes

Study Arms (2)

silicone DLT

EXPERIMENTAL

Fibreoptic intubation with silicone double lumen tube

Device: Fibreoptic intubation with silicone double lumen tube

PVC DLT

EXPERIMENTAL

Fibreoptic intubation with PVC double lumen tube

Device: Fibreoptic intubation with PVC double lumen tube

Interventions

Fibreoptic intubation with silicone double lumen tubeDEVICE

Fibreoptic intubation with silicone double lumen tube

silicone DLT
Fibreoptic intubation with PVC double lumen tubeDEVICE

Fibreoptic intubation with PVC double lumen tube

PVC DLT

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou universiry hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Study Officials

  • Dae Hee Kim, M.D.

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 26, 2019

Study Start

April 25, 2019

Primary Completion

December 19, 2019

Study Completion

December 20, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)