What this study is
The main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ETT) 180 degrees prior to intubation will decrease the incidence of postoperative throat soreness, when compared to standard technique used in Standard of Care.
What's being tested
- Direct Laryngoscope (DL)
Intervention · DEVICE
DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
- Video laryngoscope (VL)
Intervention · DEVICE
VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.
- Endotracheal Tube (ETT) 180
Intervention · PROCEDURE
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.
Study details
- Official title
- Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion to Decrease the Risk of Postoperative Sore Throat: a Randomized Double-Blind Prospective Trial.
- Sponsor
- Ohio State University
- Conditions
- Anesthesia, Endotracheal
- Enrolling
- 357 people
- Starts
- 2023-05-31
- Est. completion
- 2027-05-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- ASA I - III
- 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
You can't join if
- Age < 18 years old or age > 90 years old
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- Alberto A Uribe · Contact6142930775alberto.uribe@osumc.edu
- Jeremy Reeves · Contact6142933559jeremy.reeves@osumc.edu
Recruiting
Study team
Sponsor
Ohio State University
Study ID 2022H0220
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.