NCT03392766

Brief Summary

Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. 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 with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

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

January 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

January 2, 2018

Last Update Submit

April 22, 2019

Conditions

Intubation;DifficultThoracic Diseases

Keywords

fibreoptic intubationdouble lumen tubedifficult intubation

Outcome Measures

Primary Outcomes (1)

  • intubation time

    the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.

    through study completion, an average of 4 hour

Secondary Outcomes (5)

  • insertion time

    through study completion, an average of 4 hour

  • railroading time

    through study completion, an average of 4 hour

  • grade of ease of insertion over fibreoptic bronchoscope

    through study completion, an average of 4 hour

  • trauma around the glottis

    through study completion, an average of 4 hour

  • complication at the post-anesthesia care unit

    through study completion, an average of 4 hour

Study Arms (2)

Single lumen tube and bronchial blocker

EXPERIMENTAL

neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker

Device: single lumen tube and bronchial blocker

Double lumen tube

EXPERIMENTAL

neck collar apply. fibreoptic intubation with double lumen tube

Device: double lumen tube

Interventions

single lumen tube and bronchial blockerDEVICE

neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.

Single lumen tube and bronchial blocker
double lumen tubeDEVICE

neck collar apply. fibreoptic intubation with double lumen tube.

Double lumen tube

Eligibility Criteria

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

You may qualify if:

  • patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2

You may not qualify if:

  • abnormality of upper airway gastroesophageal disease risk of aspiration BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou universiry hospital

Suwon, Gyeonggi-do, South Korea

Location

Related Publications (1)

  • Kang S, Chae YJ, Kim DH, Bae SY, Yoo JY. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial. Sci Rep. 2023 May 24;13(1):8397. doi: 10.1038/s41598-023-35635-1.

    PMID: 37225777DERIVED

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Dae Hee Kim, M.D.

    Ajou unversity hospital

    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
Assistant Professor

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 8, 2018

Study Start

February 9, 2018

Primary Completion

April 22, 2019

Study Completion

April 22, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)