The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use

February 14, 2023 updated by: The First Hospital of Qinhuangdao

The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.

The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

Study Type

Interventional

Enrollment (Actual)

60

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

  • China
    • Hebei
      • Qinhuangdao, Hebei, China, 066000
        • The First Hospital of Qinhuangdao

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients undergoing thoracic surgery

Exclusion Criteria:

  1. Age>70 or <18 years
  2. ASA classifications >III
  3. BMI >35kg/m2
  4. Modified Mallampati classification ≥III
  5. Thoracic surgery within the last one month
  6. Severe cardiopulmonary disease

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the Length of Right Main Stem Bronchus >=15mm
Other: the Length of Right Main Stem Bronchus
The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography
Experimental: the Length of Right Main Stem Bronchus <15mm
Other: the Length of Right Main Stem Bronchus
The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of Uniblocker displacement
Time Frame: 1 year
1 year
The number of adjust the right-sided double-lumen tube to optimum location
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

The First Hospital of Qinhuangdao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 15, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 13, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2019A123

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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