Hybrid Intubation Technique for Difficult Airway Children

Failed or Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058221
• Other study ID #: H-2308-024-1457
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Jung-Bin Park, MD
• Phone: 0220723664
• Email: jb4001[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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 ? The patient or their parents do not agree to participate in the study. ? Other cases deemed unsuitable by the researcher

Related Conditions & MeSH terms

• Failed or Difficult Intubation

Intervention

Device:
• simultaneous videolaryngoscopy
Two specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope.
• supraglottic airway
After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.