Hybrid Intubation Technique for Difficult Airway Children

NCT ID: NCT06058221

Last Updated: 2023-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Failed or Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hybrid technique

Group Type EXPERIMENTAL

simultaneous videolaryngoscopy

Intervention Type DEVICE

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

Supraglottic airway

Group Type ACTIVE_COMPARATOR

supraglottic airway

Intervention Type DEVICE

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

Interventions

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simultaneous videolaryngoscopy

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

Intervention Type DEVICE

supraglottic airway

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun-hee Kim

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Bin Park, MD

Role: CONTACT

0220723664 ext. 82

Facility Contacts

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Eun-hee Kim

Role: primary

820220723664 ext. 82

Other Identifiers

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H-2308-024-1457

Identifier Type: -

Identifier Source: org_study_id

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