Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endotracheal tube.
- Who it may be relevant to
- Registry conditions: Intubation Complication. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison
Overview
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.
Interventions
- Device endotracheal tube
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.
Primary outcome measures
- First-attempt success rate of tracheal intubation [Time frame: Immediately after induction of anesthesia]
Secondary outcome measures (8)
- Incidence and grade of subglottic airway injury [Time frame: Immediately after completion of surgery (at extubation)]
- Postoperative sore throat score [Time frame: 1 hour and 24 hours postoperatively]
- Incidence of postoperative hoarseness [Time frame: 1 hour and 24 hours postoperatively]
- Cormack-Lehane grade and POGO score [Time frame: Periprocedural (during tracheal intubation)]
- Mean blood pressure [Time frame: Periprocedural (immediately before and immediately after tracheal intubation)]
- Heart rate [Time frame: Periprocedural (immediately before and immediately after tracheal intubation)]
- Oxygen saturation [Time frame: Periprocedural (immediately before and immediately after tracheal intubation)]
- Bispectral index [Time frame: Periprocedural (immediately before and immediately after tracheal intubation)]
Eligibility criteria
Inclusion criteria
- Adults aged 19 years or older
- Scheduled to undergo surgery under general anesthesia
Exclusion criteria
- 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)
- History of upper airway surgery
- High risk of aspiration or bleeding tendency
- Presence of severely loose teeth
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07682480 · 2503-040-1621