Hybrid Intubation Technique for Difficult Airway Children

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

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.

Study Overview

• Status: Recruiting
• Conditions: Failed or Difficult Intubation
• Intervention / Treatment: Device: simultaneous videolaryngoscopy; Device: supraglottic airway

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Bin Park, MD; Phone Number: 82 0220723664; Email: jb4001@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Eun-hee Kim; Phone Number: 82 820220723664; Email: beloveun@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid technique	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.
Active Comparator: Supraglottic airway	Device: supraglottic airway; After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H-2308-024-1457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No