Laryseal Pro LMA Versus Ambu Aura Gain LMA in Elective Ophthalmological Surgeries

Comparative Evaluation of the Laryseal TM Pro Laryngeal Mask Airway With Ambu Aura Gain Laryngeal Mask Airway in Anesthetized Paralyzed Adult Patients Undergoing Elective Ophthalmological Surgeries. A Randomized Controlled Study

Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation &ventilation, less hemodynamic stress response and less postoperative complications. Many health care providers do not have the requisite knowledge and enough practice to perform safe and quick intubation. For these providers, SADs can be a valid alterative especially in untrained personnel, or when tracheal intubation is impossibe.

Both devices are with a cuff modified to improve the seal around the glottis and a drainage tube to provide a bypass channel for regurgitated gastric contents, prevent gastric insufflation, and allow the passage of a gastric tube. These features are designed to improve the safety of the mask and broaden its scope, especially when used with positive pressure ventilation.

The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) that can accept tracheal tube in sizes ranging from 6.5 up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr.

The LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr. The Laryseal pro could provide a rapid and secure airway management and improve patient safety with gastric access reducing the risk of pulmonary aspiration, in addition to speeding up the ETT tube placement if needed with a unique guide system, beside to integrated fenestrated flap that protects from blockage with minimal increase in flow resistance. All these features of laryseal pro allow quick easy first time insertion success.

After approval of the Local Ethical Committee and obtaining an informed written consent from every patient, then patients will be categorized randomly into two equal groups using the computer allocation software to be put into opaque closed-envelopes: GL (n=27): Laryseal TM Pro. GA (n=27): Ambu Aura Gain.

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Masks Comparison
• Intervention / Treatment: Device: Ambu Aura Gain; Device: LarysealTM Pro

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham Ali Abdelhaleem Abdelrahman, M.D.; Phone Number: 00201009136408; Email: rehamali72@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Department of Anesthesia, Surgical ICU, and Pain Management
    • Contact: Reham Ali Abdelhaleem Abdelrahman, MD; Phone Number: 00201009136408; Email: rehamali72@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age: 18-55 years old
• ASA I& II
• Both sexes
• El-Ganzouri Airway Score < or =2

Exclusion Criteria:

• Active upper respiratory tract infections, pneumonia, COPD & exacerbated bronchial asthma.
• History of obstructive sleep apnea (OSA) or STOP Bang-Score > 4.
• Potentially full stomach (trauma, morbid obesity BMI> 35 Kg/m2, pregnancy, history of gastric regurgitation and heart burn).
• Esophageal reflux (hiatus hernia).
• Coagulation disorders.
• Patients with any cardiac conditions (IHD, RHD, decompensated heart failure and arrhythmia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LarysealTM Pro	Device: Ambu Aura Gain; The AuraGain is Ambu ꞌs 3rd generation disposable laryngeal mask, satisfying 3 fundamental airway management needs by integrating gastric access channel for managing gastric content and intubation capability using standard ET-tubes in an anatomically curved single-use device that facilitates rapid establishment of a safe airway through integrated bite absorption area that could prevent airway occlusion. Other characters include pilot balloon that identifies mask size and provides tactile indication of degree of inflation, navigation marks for guiding flexible scope and is made of phthalate-free material. Its thin and soft cuff is designed to deliver high seal pressure up to 40 cmH2O. It was presented in the clinical market in sizes 3, 4, 5 and 6 (according to the body weight; size 3: 30-50 kg, size 4: 50-70 kg, size 5: 70-100 kg, and size 6: >100 kg) with maximum suction catheter size of 16 Fr.
Other: Ambu Aura Gain	Device: LarysealTM Pro; The LarysealTM Pro is the new generation mask for safe and effective airway management, as it could reduce the risk of aspiration by the integrated suction catheter port to allow effective removal of fluids and gastric contents. So that, it could be a promising airway device as its symmetrical cuff and tube contoured to match the oropharyngeal anatomy for quick and easy first time insertion success. It could be applied in both routine and advanced airway management for patients with a higher risk of a difficult airway, unexpected intubation difficulties, beside to airway control during anesthesia. It was presented in the clinical market in sizes 3, 4 and 5 (according to the body weight; size 3: 30-50Kg, size 4: 50-70 Kg, and size 5:70-100Kg) that can accept larger tracheal tube up to 7.5 and 8mm inner diameter respectively with maximum suction catheter size of 16 Fr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure (OLP) (cmH2O)	It is defined as the pressure at which leak starts. It will be calculated by the following steps : the adjustable pressure limit valve of the circle system is set at 60 cmH2O (airway pressures not allowed to exceed 40 cmH2O), the fixed fresh gas flow is set at 3 l.min-1, then the airway pressure is measured on the breathing system pressure gauge, so that leak pressure is considered as the achieved plateau airway pressure while the patient is apneic. At this stage an audible leak at the mouth (sound of gas escaping from mouth heard by listening close to patient's mouth) and stomach (sound of gas escaping into esophagus heard by auscultation over epigastrium) will be ascertained. To ensure safety, maximal allowable OLP will be fixed at 40 cmH2O	It will be measured at 5,15,30,45 and 60 minutes after successful SAD placement and effective ventilation.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Reham Ali Abdelhaleem Abdelrahman, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): May 17, 2024
• Study Completion (Estimated): July 17, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MK-2023

Drug and device information, study documents

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