Hybrid Intubation Technique for Difficult Airway Children

Study Overview
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Brief Summary
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To compare two hybrid techniques, flexible bronchoscopy-guided intubation with a video laryngoscope and flexible bronchoscopy-guided intubation with a laryngeal mask, that have recently shown promise as a way to increase first-attempt success rates and reduce complications in children with anticipated difficult intubation.

Official Title
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Fiberoptic Intubation With Simultaneous Video-laryngoscopy Versus Through a Supraglottic Airway in Children With a Difficult Airway: a Randomized Controlled Trial

Conditions
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Failed or Difficult Intubation

Intervention / Treatment
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* Device: simultaneous videolaryngoscopy
* Device: supraglottic airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from 1 month of age to less than 12 years of age who are expected to have a difficult intubation when undergoing routine surgery under general anesthesia. Exclusion Criteria: When there is limited mouth opening, making it difficult to insert supraglottic airway ② The patient or their parents do not agree to participate in the study. ③ Other cases deemed unsuitable by the researcher

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid technique<br> | Device: simultaneous videolaryngoscopy<br>* Two specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope.<br>|
| Active Comparator: Supraglottic airway<br> | Device: supraglottic airway<br>* After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt intubation success rate | The success rate of a healthcare provider's first attempt to insert a tube into a patient's airway. Intubation is defined as successful if the tube is inserted and capnography is first seen. If the fiberoptic bronchoscope comes out of the mouth, it is a failure. | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total intubation time (seconds) | Time from when the performer ends mask ventilation to when capnography first appears. | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Number of intubation attempts | Total number of attempts to intubate, regardless of the method used (failures include bronchoscopy out of the mouth, videolaryngoscope or supraglottic airway out of the mouth, or retrying manual ventilation, even if the method is the same). | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| successful tracheal intubation with the allocated method | Whether successful in intubation according to the allocated method or not | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| successful tracheal intubation (Yes or No) | To define and confirm that successful intubation occurs when the endotracheal tube is successfully placed inside the trachea, capnography is visible, and surgery can proceed as a result of successful endotracheal intubation. | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Nadir oxygen saturation during intubation (SpO2 value, %) | the minimum oxygen saturation reported during intubation periods | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology) | the trends of oxygen reserve index during intubation period per 5 seconds | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| intubation-related complication | Complications associated with intubation (airway injury, esophageal intubation, laryngospasm, bronchospasm, intraoral bleeding, arrhythmia, cardiac arrest). | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV) | Degree of vocal cord exposure, as determined by the Modified Cormack-Lehane grade, when a flexible bronchoscope is inserted by the anesthesiologist. | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. |