NCT06231342

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
May 2023May 2027

Study Start

First participant enrolled

May 31, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

January 12, 2024

Last Update Submit

April 23, 2026

Conditions

Anesthesia, Endotracheal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Incidence of hoarseness/sore throat

    24 hours after Endotracheal Tube (ETT) placement

  • Severity of hoarseness/sore throat

    24 hours after Endotracheal Tube (ETT) placement

  • Incidence of analgesic medication requirements to treat sore throat.

    24 hours after Endotracheal Tube (ETT) placement

Study Arms (3)

Direct Laryngoscopy (DL)

ACTIVE COMPARATOR

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

Device: Direct Laryngoscope (DL)

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

ACTIVE COMPARATOR

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

Device: Direct Laryngoscope (DL)Procedure: Endotracheal Tube (ETT) 180

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

ACTIVE COMPARATOR

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

Device: Video laryngoscope (VL)Procedure: Endotracheal Tube (ETT) 180

Interventions

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.

Direct Laryngoscopy (DL)Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver
Video laryngoscope (VL)DEVICE

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

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

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.

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Subjects and research personnel assessing subjects during follow-ups will be blinded throughout the study. Only the clinicians inside the operative room will be unblinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A prospective double-blinded randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 30, 2024

Study Start

May 31, 2023

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

US(1)