Compare a New Method and Formula as a Guide for the Intubation of a Left-sided Double-lumen Tube

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

Compare the Accuracy of the Distances Between the Midpoint of the Thyroid Cartilage to Suprasternal Notch Base on Body Surface Measurement Add the Distance Between Suprasternal Notch to Carina of Trachea According to Chest CT and Formula Base on Patient's Height as a Guide for the Intubation of a Left-sided Double-lumen Tube

One-lung ventilation (OLV) is required for the most of thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) is the commonly used device for OLV. The objective of this study was to compare the accuracy of the distances between vocal cords to carina of trachea and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

In previous study, investigators found that the distances between vocal cords to carina of trachea was a useful predictive method for the intubation of a Left-sided Double-lumen tube. However in some hospitals preoperative chest CT scans not contain the vocal cords slice. So in this study investigators will compare the accuracy of the distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT and formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.

Study Type

Observational

Enrollment (Actual)

60

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

    • Hebei
      • Qinhuangdao, Hebei, China, 066000
        • 中国

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. Age<18 or >70 years
  2. ASA>III; BMI>35kg/m2
  3. Without suspected tuberculosis or systemic infection
  4. Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway

Description

Inclusion Criteria:

  1. Adult patients undergoing elective left side thoracic surgery
  2. Requiring a Uniblocker or DLT for one-lung ventilation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Measurement
The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT.
The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT
Formula

The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube.

The depth of intubation = 0.1977* height-4.2423

The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of the injuries of bronchi and carina
Time Frame: 1-3days
The degree of bronchi and carina injuries: 1 clear; 2 a few petechiae; 3coalesced petechiae, hemorrhage, or ecchymosis; 4 erosion
1-3days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of dislodgement
Time Frame: 1 day
The incidence of dislodgement after repositioning
1 day
The intubation time
Time Frame: 1-5min
The intubation time (IT) was defined as the time from the anesthesiologist inserted the video laryngoscope between the teeth of patients until the double lumen-tube at the optimal position checked by Fiberoptic bronchoscopy
1-5min

Collaborators and Investigators

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

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)

June 15, 2018

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

December 13, 2018

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 4, 2018

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

  • 98776

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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