Hybrid Intubation Technique for Difficult Airway Children
- Conditions
- Failed or Difficult Intubation
- Interventions
- Device: supraglottic airwayDevice: simultaneous videolaryngoscopy
- Registration Number
- NCT06058221
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supraglottic airway supraglottic airway - Hybrid technique simultaneous videolaryngoscopy -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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).
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 (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.
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
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
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
Trial Locations
- Locations (1)
Seoul national university hospital
🇰🇷Seoul, Korea, Republic of