A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population

NCT06945029 | Recruiting

• 1 other identifier: MD-38-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.

Conditions

Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• The FOB-guided intubation time using the EAD in seconds

  the time elapsing between circuit disconnection from the EAD for the purpose of bronchoscope-guided intubation till reconnecting the circuits to the ETT and appearance of capnography waves.

  First 10 seconds of intubation

Study Arms (2)

Ambu Aura Gain extraglottic device group

ACTIVE COMPARATOR

In this group, Ambu Aura Gain extraglottic device will be used as a conduit for fiberoptic endotracheal intubation.

Device: Ambu Aura Gain

Laryseal pro extraglottic device groupI

ACTIVE COMPARATOR

In this group, Laryseal pro extraglottic device will be used as a conduit for fiberoptic endotracheal intubation.

Device: Laryseal Pro

Interventions

Ambu Aura Gain DEVICE

compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.

Ambu Aura Gain extraglottic device group

Laryseal Pro DEVICE

compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric

Laryseal pro extraglottic device groupI

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age starting from 4 years to 8 years.
• Both genders.
• ASA physical status class I-ll.
• Apparently anatomically normal with normal percentile growth chart, not suspected to have difficult airway.
• Scheduled for day case surgeries more than one hour under general anesthesia.

You may not qualify if:

• Parents refusal.
• Abnormality in head and neck or craniofacial anomalies as Piere Robbin syndrome, facial trauma, head and neck tumours, swellings and hemangiomas.
• Patients at risk of regurgitation and pulmonary aspiration such as patients with hiatus hernia, GERD or DM.
• Abnormal or contraindicated cervical spine flexion/extension/rotation.
• Allergy to any EAD components.
• Any active respiratory or cardiac disease and metabolic disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Giza Governorate, 1111, Egypt

RECRUITING

Study Officials

• Jehan A El-kholy, Professor

  Cairo University

  STUDY CHAIR

• Maha M.I Youssef, Assistant Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Omnia Y Kamel, Doctorate degree

CONTACT

01270130326; omniayehiakamel90@gmail.com

Eman S Hassan Mohammed, Resident

CONTACT

01113342616; emankreem10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical intensive care and pain management

Model Details: A prospective Randomized Controlled Study.

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: April 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)