- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545737
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
Conditions
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
-
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Hebei
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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
- Age<18 or >70 years
- ASA>III; BMI>35kg/m2
- Without suspected tuberculosis or systemic infection
- Without severe cardiopulmonary disease, preoperative hoarseness and anticipated difficult airway
Description
Inclusion Criteria:
- Adult patients undergoing elective left side thoracic surgery
- 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
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