Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

January 5, 2018 updated by: DAE HEE KIM, Ajou University School of Medicine

Comparison of Insertion Time Over Fiberoptic Bronchoscope Between Double Lumen Tube and Single Lumen Tube

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 Anesthesiology Physical status 1,2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single lumen tube
fiberoptic intubation with single lumen tube with bronchial blocker.
Device: single lumen tube and bronchial blocker
fiberoptic intubation with single lumen tube and bronchial blocker
Experimental: double lumen tube
fiberoptic intubation with double lumen tube.
Device: double lumen tube
fiberoptic intubation with double umen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: at anesthesia induction
time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus
at anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Dae Hee Kim, M.D., Ajou unversity hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Actual)

August 26, 2017

Study Completion (Actual)

August 26, 2017

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AJIRB-DEV-OBS-17-70

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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