- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008473
Chest CT for the Placement of the Uniblocker
February 22, 2018 updated by: The First Hospital of Qinhuangdao
Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography
Video laryngoscope and chest CT iminge for the placement of the Uniblocker
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker
Study Type
Interventional
Enrollment (Actual)
70
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
-
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Hebei
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Qinhuangdao, Hebei, China, 066000
- The First Hospital of Qinhuangdao
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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 65 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 Under general anesthesia
Exclusion Criteria:
- Age younger than 18 yr or older than 65 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: video laryngoscope and chest CT iminge
First,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker.
Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina
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|
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Experimental: Conventional intubation of Uniblocker
First, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope.
Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus.
Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Intubation Time
Time Frame: 5min
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5min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ximing Qi, PHD, The First Hospital of Qinhuangdao
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)
January 1, 2017
Primary Completion (Actual)
September 24, 2017
Study Completion (Actual)
September 24, 2017
Study Registration Dates
First Submitted
December 29, 2016
First Submitted That Met QC Criteria
December 29, 2016
First Posted (Estimate)
January 2, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 20161229
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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