Hybrid Intubation Technique for Difficult Airway Children

NCT06058221 | Unknown

• 1 other identifier: H-2308-024-1457
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed or Difficult Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• total intubation time (seconds)

  from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

• Number of intubation attempts

  from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

• successful tracheal intubation with the allocated method

  from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

• successful tracheal intubation (Yes or No)

  from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

• Nadir oxygen saturation during intubation (SpO2 value, %)

  from induction of anesthesia to 1 minutes after intubation, about 10 minutes.

Study Arms (2)

Hybrid technique

EXPERIMENTAL

Device: simultaneous videolaryngoscopy

Supraglottic airway

ACTIVE COMPARATOR

Device: supraglottic airway

Interventions

simultaneous videolaryngoscopy DEVICE

Two specialists perform tracheal intubation, one using a video laryngoscope to expose the vocal cords and the other using a fiberoptic bronchoscope.

Hybrid technique

supraglottic airway DEVICE

After inserting the supraglottic airway, the specialist performs intubation using a fiberoptic bronchoscope through the supraglottic airway.

Supraglottic airway

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, 03080, South Korea

RECRUITING

Central Study Contacts

Jung-Bin Park, MD

CONTACT

0220723664; jb4001@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: October 6, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

KR (1)