Clinical trial NCT06231342: Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia, Endotracheal
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective double-blinded randomized trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The researcher who is not blinded will randomize the patient to one of the three groups.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Incidence of postoperative sore throat
timeFrame: 24 hours after Endotracheal Tube (ETT) placement
Secondary outcomes:
measure: Incidence of hoarseness/sore throat
timeFrame: 24 hours after Endotracheal Tube (ETT) placement
measure: Severity of hoarseness/sore throat
timeFrame: 24 hours after Endotracheal Tube (ETT) placement
measure: Incidence of analgesic medication requirements to treat sore throat.
timeFrame: 24 hours after Endotracheal Tube (ETT) placement
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: