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.

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Endotracheal
• Intervention / Treatment: Device: Direct Laryngoscope (DL); Device: Video laryngoscope (VL); Procedure: Endotracheal Tube (ETT) 180

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 Type: Interventional
• Enrollment (Estimated): 357
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Alberto A Uribe; Phone Number: 614-293-0775; Email: alberto.uribe@osumc.edu
      • Contact: Jeremy Reeves; Phone Number: 6142933559; Email: jeremy.reeves@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct Laryngoscopy (DL); Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.	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.
Active Comparator: Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver; Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.	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.; 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.
Active Comparator: Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE); Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hoarseness/sore throat	To assess the incidence of hoarseness/sore throat	24 hours after Endotracheal Tube (ETT) placement
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
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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022H0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No