Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT06231342
- Status
- Recruiting
Conditions
- Anesthesia, Endotracheal
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Direct Laryngoscope (DL) — DEVICEDL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation.
- Video laryngoscope (VL) — DEVICEVL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video.
- Endotracheal Tube (ETT) 180 — PROCEDUREA 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.
Study Details
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.
Key Dates
- Start date
- May 31, 2023
- Status verified
- Apr 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 357 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Direct Laryngoscopy (DL)Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.
- Active Comparator: Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuverStandard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
- 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.
Primary Outcome Measure
Incidence of postoperative sore throat [ Time Frame: 24 hours after Endotracheal Tube (ETT) placement ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 |
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