Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
NCT ID: NCT06231342
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
357 participants
INTERVENTIONAL
2023-05-31
2027-05-31
Brief Summary
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Detailed Description
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Specific technique and procedure:
* Investigators anesthesiologists assigned to perform the laryngoscopies will be limited to 6 with minimum 2 years of attending experiences to balance the variability. The results of inter-operator bias will be analyzed.
* Endotracheal Tube (ETT) size will be: 7.0 for men and women unless there will be clinical indications to use a different size of Endotracheal Tube.
* Stylet preparation: 75-degree angulation shaped preoperatively and ready for use
* Blade for either McGrath, Macintosh, or direct laryngoscopy will be size 3 for women and size 4 for men.
* Endotracheal Tube (ETT) 180: inserting endotracheal tube loaded with stylet, rotating the tube 180 degree clockwise as soon as the tube tip passes the vocal cords (glottis), and removing the stylet after the tube cuff passes through the vocal cords, which is a common practice.
* Endotracheal Tube cuff filling air pressure will be 20 cmH2O. Inflation will be made using a hand-held airway pressure manometer.
* Patient's data collection will be blinded for both patient and Investigators anesthesiologists assigned to perform the laryngoscopies
* No medications including opiates, monitoring options, and medical decisions will be altered by the study.
A member of the research team will follow-up (in person or phone-call) with each patient in the Post Anesthesia Care Unit (PACU) and 24+/- 3 hours after endotracheal tube removal to collect information regarding any symptoms of hoarseness or sore throat.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Direct Laryngoscopy (DL)
Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.
Direct Laryngoscope (DL)
DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver
Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
Direct Laryngoscope (DL)
DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
Endotracheal Tube (ETT) 180
A novel maneuver has been described to decrease the insult from stylet named Endotracheal Tube (ETT) 180; a clockwise rotation of the stylet-loaded Endotracheal Tube (ETT) 180 degrees on its axis right after the tip of Endotracheal Tube (ETT) passes the patient's vocal cords (glottis) before fully inserting the Endotracheal Tube (ETT) and then, pulling the stylet out. This maneuverer allows the stylet to match the posterior angulation of the trachea.
Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)
Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
Video laryngoscope (VL)
VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.
Endotracheal Tube (ETT) 180
A novel maneuver has been described to decrease the insult from stylet named Endotracheal Tube (ETT) 180; a clockwise rotation of the stylet-loaded Endotracheal Tube (ETT) 180 degrees on its axis right after the tip of Endotracheal Tube (ETT) passes the patient's vocal cords (glottis) before fully inserting the Endotracheal Tube (ETT) and then, pulling the stylet out. This maneuverer allows the stylet to match the posterior angulation of the trachea.
Interventions
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Direct Laryngoscope (DL)
DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
Video laryngoscope (VL)
VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.
Endotracheal Tube (ETT) 180
A novel maneuver has been described to decrease the insult from stylet named Endotracheal Tube (ETT) 180; a clockwise rotation of the stylet-loaded Endotracheal Tube (ETT) 180 degrees on its axis right after the tip of Endotracheal Tube (ETT) passes the patient's vocal cords (glottis) before fully inserting the Endotracheal Tube (ETT) and then, pulling the stylet out. This maneuverer allows the stylet to match the posterior angulation of the trachea.
Eligibility Criteria
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Inclusion Criteria
* Ambulatory patients undergoing general anesthesia with an Endotracheal Tube (ETT) placement
* Admitted patients undergoing general anesthesia an Endotracheal Tube (ETT) placement
* Age \> 18 and \< 90 years old
* BMI \< 50
Exclusion Criteria
* Pregnant women
* Prisoners
* Any surgery involving the pharynx, larynx, vocal cords, trachea that will create confounding factors related to postoperative sore throat
* History of difficult airway
* Critically ill patients requiring intensive care
18 Years
90 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Suren Soghomonyan
Assistant Professor
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Facility Contacts
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Other Identifiers
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2022H0220
Identifier Type: -
Identifier Source: org_study_id
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