NCT06231342

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, Endotracheal

Interventions

Type	Name	Description
DEVICE	Direct Laryngoscope (DL)	DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
DEVICE	Video laryngoscope (VL)	VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.
PROCEDURE	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.

Timeline

• Start date: 2023-05-31
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-01-30
• Last updated: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study