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NCT Number: NCT06231342

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

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.

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Key information

Conditions

Anesthesia, Endotracheal

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct Laryngoscope (DL)

Device

DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.

Video laryngoscope (VL)

Device

VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.

Endotracheal Tube (ETT) 180

Procedure

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.

Primary outcomes

  1. Incidence of postoperative sore throat

    Time frame: 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 outcomes

  1. Incidence of hoarseness/sore throat

    Time frame: 24 hours after Endotracheal Tube (ETT) placement

    To assess the incidence of hoarseness/sore throat

  2. Severity of hoarseness/sore throat

    Time frame: 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.

  3. Incidence of analgesic medication requirements to treat sore throat.

    Time frame: 24 hours after Endotracheal Tube (ETT) placement

    To assess the incidence of analgesic medication to treat sore throat sensation.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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