Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-11-08
2023-09-21
Brief Summary
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Detailed Description
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The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location.
Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate "yes" or "no" for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated "yes" for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10.
Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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EndoClip
Clip applied to endotracheal tube.
EndoClip
Clip attached to mid portion of the endotracheal tube.
No Clip
No clip applied to endotracheal tube.
No interventions assigned to this group
Interventions
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EndoClip
Clip attached to mid portion of the endotracheal tube.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is not undergoing a procedure in the head and neck region
Exclusion Criteria
* Patient undergoing surgery in the head and neck region
18 Years
ALL
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Andrew Vahabzadeh-Hagh
Associate Professor of Surgery
Principal Investigators
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Andrew Vahabzadeh-Hagh, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego Health
Locations
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UC San Diego Health
La Jolla, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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800842
Identifier Type: -
Identifier Source: org_study_id
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