Anesthesia, EndotrachealNCT06231342
Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion
A study testing Direct Laryngoscope (DL), Video laryngoscope (VL) and Endotracheal Tube (ETT) 180 in people with Anesthesia, Endotracheal, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia, Endotracheal
- What is being tested?
- Direct Laryngoscope (DL), Video laryngoscope (VL) and Endotracheal Tube (ETT) 180
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alberto A Uribe, 6142930775, alberto.uribe@osumc.edu
Jeremy Reeves, 6142933559, jeremy.reeves@osumc.edu
About this study
Official 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.
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.
Read the 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.
- Conditions
- Anesthesia, Endotracheal
- Being tested
- Direct Laryngoscope (DL), Video laryngoscope (VL), Endotracheal Tube (ETT) 180
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) 180Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscopy (DL) | Active comparator | Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation. Receives: 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. Receives: 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. Receives: Device: Video laryngoscope (VL); Procedure: Endotracheal Tube (ETT) 180 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after Endotracheal Tube (ETT) placement
Secondary outcomes (3)
Incidence of hoarseness/sore throat
To assess the incidence of hoarseness/sore throat
Measured: 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.
Measured: 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.
Measured: 24 hours after Endotracheal Tube (ETT) placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start31 May 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EndotrachealStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective double-blinded randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 357 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suren Soghomonyan, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231342
- Sponsor's protocol ID
- 2022H0220
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06231342
- Acronym / sponsor ID
- 2022H0220
- Conditions
- Anesthesia, Endotracheal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 357 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective double-blinded randomized trial
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscopy (DL) | Active comparator | Device: Direct Laryngoscope (DL)Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation. |
| Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver | Active comparator | Device: Direct Laryngoscope (DL), Procedure: Endotracheal Tube (ETT) 180Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation. |
| Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE) | Active comparator | Device: Video laryngoscope (VL), Procedure: Endotracheal Tube (ETT) 180Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Laryngoscope (DL)DL allows visualization of the larynx. It is used during general anesthesia, for surgical procedures of the larynx, and during resuscitation. | Device | Direct Laryngoscopy (DL), Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver |
| Video laryngoscope (VL)VL facilitates intubation while allowing clinicians to share and record real-time high-resolution images and video. | Device | Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE) |
| Endotracheal Tube (ETT) 180A 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. | Procedure or surgery | Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver, Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE) |
Primary outcome
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.
3 secondary outcomes
Incidence of hoarseness/sore throat
Time frame: 24 hours after Endotracheal Tube (ETT) placement
Severity of hoarseness/sore throat
Time frame: 24 hours after Endotracheal Tube (ETT) placement
Incidence of analgesic medication requirements to treat sore throat.
Time frame: 24 hours after Endotracheal Tube (ETT) placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia, Endotracheal
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Recruiting
Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery
Analgesics, Opioid, Anesthesia, Endotracheal
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
Recruiting
BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
Endotracheal Extubation, Airway Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Wexner Medical Center
Columbus, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Laryngoscope (DL), Video laryngoscope (VL) and Endotracheal Tube (ETT) 180 in people with Anesthesia, Endotracheal, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative sore throat (time frame: 24 hours after Endotracheal Tube (ETT) placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.