- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943928
Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance
February 13, 2023 updated by: The First Hospital of Qinhuangdao
laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Comparing the traditional method of double lumen endotracheal tube intubation and laryngoscope combined with chest CT guide the precise localization of double lumen endotracheal tube
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
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI less than 35 kg/m2
- ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-
Exclusion Criteria:
- Exclusion criteria included age younger than 18 yr
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: laryngoscope and chest CT image
First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube.
Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis.
|
First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube.
Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis
|
Experimental: Traditional method by experience
Operator inserted the double lumen tube by experience
|
Operator inserted the double lumen tube by experience
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intubation Time
Time Frame: Ten minutes
|
Ten minutes
|
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
October 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
October 23, 2016
First Submitted That Met QC Criteria
October 23, 2016
First Posted (Estimate)
October 25, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2016A123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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