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

The Ohio State University

Status: Enrolling

Conditions: Anesthesia, Endotracheal

Treatments: Device: Video laryngoscope (VL); Device: Direct Laryngoscope (DL); Procedure: Endotracheal Tube (ETT) 180

Study type: Interventional

Funder types: Other

Identifiers

NCT06231342

2022H0220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 357 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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357 participants in 3 patient groups

Direct Laryngoscopy (DL)

Active Comparator group

Description:

Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.

Treatment:

Device: Direct Laryngoscope (DL)

Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver

Active Comparator group

Description:

Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.

Treatment:

Procedure: Endotracheal Tube (ETT) 180

Device: Direct Laryngoscope (DL)

Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)

Active Comparator group

Description:

Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.

Treatment:

Procedure: Endotracheal Tube (ETT) 180

Device: Video laryngoscope (VL)