Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion

Not Applicable

Recruiting

• Conditions: Anesthesia, Endotracheal
• Interventions: Device: Direct Laryngoscope (DL); Device: Video laryngoscope (VL); Procedure: Endotracheal Tube (ETT) 180

• Registration Number: NCT06231342
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 357

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Laryngoscopy (DL)	Direct Laryngoscope (DL)	Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.
Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver	Direct Laryngoscope (DL)	Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver	Endotracheal Tube (ETT) 180	Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)	Endotracheal Tube (ETT) 180	Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)	Video laryngoscope (VL)	Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative sore throat	24 hours after Endotracheal Tube (ETT) placement	To assess the differences in incidence of postoperative sore throat after intubation between the conventional technique and ETT 180 rotation of the ETT.

Secondary Outcome Measures

Name	Time	Method
Incidence of hoarseness/sore throat	24 hours after Endotracheal Tube (ETT) placement	To assess the incidence of hoarseness/sore throat
Severity of hoarseness/sore throat	24 hours after Endotracheal Tube (ETT) placement	To assess the severity of hoarseness/sore throat using a 0-3-point scale (units), where 0 = no hoarneseness/sore throat at all and and 3 = very bad hoarseness/sore throat sensation.
Incidence of analgesic medication requirements to treat sore throat.	24 hours after Endotracheal Tube (ETT) placement	To assess the incidence of analgesic medication to treat sore throat sensation.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States