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

Anesthesia, Endotracheal Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231342
• Other study ID #: 2022H0220
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 357
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Endotracheal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative sore throat	To assess the differences in incidence of postoperative sore throat after intubation between the conventional technique and ETT 180 rotation of the ETT.	24 hours after Endotracheal Tube (ETT) placement
Secondary	Incidence of hoarseness/sore throat	To assess the incidence of hoarseness/sore throat	24 hours after Endotracheal Tube (ETT) placement
Secondary	Severity of hoarseness/sore throat	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.	24 hours after Endotracheal Tube (ETT) placement
Secondary	Incidence of analgesic medication requirements to treat sore throat.	To assess the incidence of analgesic medication to treat sore throat sensation.	24 hours after Endotracheal Tube (ETT) placement