Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups. In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 years or older

Scheduled to undergo surgery under general anesthesia

Disqualifiers

Refusal to participate in the study

History of gastroesophageal reflux disease

Inadequate preoperative fasting

Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)

Trial design

Design model

Parallel

Treatments tested in this trial

  • endotracheal tube

    Device

    Tracheal intubation is performed using a videolaryngoscope without a stylet. In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used. Intubation is conducted after induction of general anesthesia. Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed. Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.

Treatment groups

246 Participants
are divided into 2 treatment groups
Group A: oral RAE tube groupExperimental treatment 1 intervention
Group B: reinforced tube groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

First-attempt success rate of tracheal intubation

The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.

Time frame
Immediately after induction of anesthesia

Secondary outcomes

1

Incidence and grade of subglottic airway injury

Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale

Time frame
Immediately after completion of surgery (at extubation)
2

Postoperative sore throat score

Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.

Time frame
1 hour and 24 hours postoperatively
3

Incidence of postoperative hoarseness

Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.

Time frame
1 hour and 24 hours postoperatively
4

Cormack-Lehane grade and POGO score

Airway visualisation was assessed during tracheal intubation using the Cormack-Lehane grading system (Grade I-IV, where Grade I indicates full view of the glottis and Grade IV indicates no visible glottic structures; lower grades indicate better glottic visualisation) and the Percentage of Glottic Opening (POGO) score (0-100%, where higher scores indicate better glottic visualisation).

Time frame
Periprocedural (during tracheal intubation)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: