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

ConditionAnesthesia, Endotracheal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorOhio State University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/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.

Treatment groups

357 Participants
are divided into 3 treatment groups
Group A: Direct Laryngoscopy (DL)Active comparator 1 intervention
Group B: Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuverActive comparator 2 interventions
Group C: Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)Active comparator 2 interventions

Trial outcomes

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.

Time frame
24 hours after Endotracheal Tube (ETT) placement

Secondary outcomes

1

Incidence of hoarseness/sore throat

To assess the incidence of hoarseness/sore throat

Time frame
24 hours after Endotracheal Tube (ETT) placement
2

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.

Time frame
24 hours after Endotracheal Tube (ETT) placement
3

Incidence of analgesic medication requirements to treat sore throat.

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

Time frame
24 hours after Endotracheal Tube (ETT) placement

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov
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