NCT03173443

Brief Summary

One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT. The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

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

May 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

May 30, 2017

Last Update Submit

January 5, 2018

Conditions

Intubation;Difficult

Keywords

Fiberoptic intubationdouble lumen tube

Outcome Measures

Primary Outcomes (1)

  • insertion time

    time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus

    at anesthesia induction

Study Arms (2)

single lumen tube

EXPERIMENTAL

fiberoptic intubation with single lumen tube with bronchial blocker.

Device: single lumen tube and bronchial blocker

double lumen tube

EXPERIMENTAL

fiberoptic intubation with double lumen tube.

Device: double lumen tube

Interventions

single lumen tube and bronchial blockerDEVICE

fiberoptic intubation with single lumen tube and bronchial blocker

single lumen tube
double lumen tubeDEVICE

fiberoptic intubation with double umen 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 and one lung ventilation American Society of Anesthesiology 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, 16499, South Korea

Location

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
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

May 31, 2017

Primary Completion

August 26, 2017

Study Completion

August 26, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)