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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation
• Intervention / Treatment: Device: Ambu Aura Gain; Device: Laryseal Pro

Detailed Description

Airway management is a skill that must be mastered by all anesthesiologists. Since the introduction of the extraglottic airway devices (EADs) in the early 1980s, the EAD has become a central element in the management of airway in adults and children. Some of the EADs are specially designed to allow endotracheal intubation whether blindly or with the use of fiberoptic bronchoscope (FOB). So, with the use of EAD, it is possible to provide adequate oxygenation and at the same time perform fibreoptic bronchoscopy-guided trans-device intubation, providing less hemodynamic stress response and less postoperative complications. As patient's safety always comes first, the use of flexible bronchoscopes became more widespread, strong literature favored visualization of the glottis over blind intubation. So, the use of the intubating EADs as aconduit for fiberoptic intubation is favoured over blind intubation. In addition, FOB guided intubation through EAD is a central step in the algorithm of the expected as well as the unexpected difficult airway in children.

The Ambu Aura Gain is a second-generation EAD which was presented in the clinical field in 2018. It is characterized by a wide inner diameter tunnel which has a C shaped curve with an angle guiding the endotracheal tube (ETT) into the laryngeal inlet. The presence of gastric access through a second port helps to vent the stomach and for gastric suctioning. In a previous study The Ambu Aura Gain has been shown to be an effective conduit for FOB guided intubation regarding feasibility of FOB-guided intubation, oropharyngeal leak pressure, gastric leak pressure and fibreoptic view in small children.

Laryseal Pro is a novel device and a new generation of EADs that was developed in 2018. It is believed to be a method for rapid, secure airway management which improves patient safety with gastric access. It has a catheter channel for efficient removal of fluids and gastric content, reducing risk of aspiration and integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. Besides, it elevates the epiglottis for easy trauma-free ETT or bronchoscope insertion. In spite of that, it's clinical performance and efficacy as a conduit for fiberoptic tracheal intubation in pediatric population hasn't been studied by any study in literature till the present time.

To our knowledge, this is the first study to evaluate the clinical efficacy of laryseal Pro EGA in pediatric population. In this study we will compare between two extra glottic devices, Laryseal Pro and Ambu Aura Gain regarding clinical performance and efficacy with respect to the time of endotracheal intubation through fibreoptic, laryngeal view grade, airway seal pressure, success rate of intubation, number of attempts of intubation, number of attempts of SGA insertion and complications in pediatric population.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omnia Y Kamel, Doctorate degree; Phone Number: 01270130326; Email: omniayehiakamel90@gmail.com
• Study Contact Backup: Name: Eman S Hassan Mohammed, Resident; Phone Number: 01113342616; Email: emankreem10@gmail.com

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1111
      • Recruiting
      • Faculty of medicine, Cairo University
      • Contact: Omnia Y Kamel, Doctorate degree; Phone Number: 01270130326; Email: omniayehiakamel90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambu Aura Gain extraglottic device group; In this group, Ambu Aura Gain extraglottic device will be used as a conduit for fiberoptic endotracheal intubation.	Device: Ambu Aura Gain; compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric population.
Active Comparator: Laryseal pro extraglottic device groupI; In this group, Laryseal pro extraglottic device will be used as a conduit for fiberoptic endotracheal intubation.	Device: Laryseal Pro; compare between Laryseal Pro and Ambu Aura Gain extraglottic devices as conduits for fiberoptic endotracheal intubation regarding time of endotracheal intubation in pediatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Jehan A El-kholy, Professor, Cairo University; Study Director: Maha M.I Youssef, Assistant Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: MD-38-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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