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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.
The researcher who is not blinded will randomize the patient to one of the three groups.
Specific technique and procedure:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Laryngoscopy (DL) | Active Comparator | 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 | Standard 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 | Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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A prospective double-blinded randomized trial
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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.
| 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. |
|
| 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 |