Clinical trial NCT06945029: A Comparative Study Between Laryseal Pro Extraglottic Device and Ambu Aura Gain Laryngeal Mask as a Conduit for Fiberoptic Tracheal Intubation in Pediatric Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryseal Pro and Ambu Aura Gain as Conduits for Fiberoptic Endotracheal Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized Controlled Study.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The FOB-guided intubation time using the EAD in seconds
timeFrame: First 10 seconds of intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Jehan A El-kholy, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Maha M.I Youssef, Assistant Professor
role: STUDY_DIRECTOR
References: