Failed or Difficult Intubation
Conditions
Brief summary
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.
Interventions
DEVICEsimultaneous videolaryngoscopy
Two specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope.
DEVICEsupraglottic airway
After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| first attempt intubation success rate | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation attempts | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 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). |
| successful tracheal intubation with the allocated method | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | Whether successful in intubation according to the allocated method or not |
| successful tracheal intubation (Yes or No) | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 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. |
| total intubation time (seconds) | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | Time from when the performer ends mask ventilation to when capnography first appears. |
| Oxygen reserve index during intubation (ORi™, Rainbow Signal Extraction Technology) | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | the trends of oxygen reserve index during intubation period per 5 seconds |
| intubation-related complication | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | Complications associated with intubation (airway injury, esophageal intubation, laryngospasm, bronchospasm, intraoral bleeding, arrhythmia, cardiac arrest). |
| The degree of vocal cord exposure assessed with a flexible bronchoscope. (Modified Cormack-Lehane grade, I/II/III/IV) | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | Degree of vocal cord exposure, as determined by the Modified Cormack-Lehane grade, when a flexible bronchoscope is inserted by the anesthesiologist. |
| Nadir oxygen saturation during intubation (SpO2 value, %) | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | the minimum oxygen saturation reported during intubation periods |
Countries
South Korea
Contacts
Primary ContactJung-Bin Park, MD
Outcome results
None listed