Evaluating BASKA mask ventilation in ear surgeries

Efficiency and Safety of BASKA Mask Ventilation in Comparison With Endotracheal Intubation During Otologic Surgery in the Lateral Head and Neck Position

This study is testing if the BASKA mask can safely and effectively help with breathing during ear surgeries instead of using a traditional breathing tube.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Assiut University (other)
• Locations: 1 site (Asyut, Assiut Governorate)
• Trial ID: NCT05748782 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficiency and safety of the BASKA mask for ventilation compared to traditional endotracheal intubation during otologic surgeries performed with patients in a lateral position. The primary focus is on measuring intraoperative peak inspiratory pressure, while secondary outcomes include lung mechanics, oropharyngeal leak pressure, ventilation scores, and any perioperative adverse effects. The study aims to determine if the BASKA mask can provide a safer and more effective alternative for airway management in these surgical procedures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 undergoing general anesthesia for ear surgeries in a lateral neck position.

Not a fit: Patients with a history of cardiac or respiratory diseases, psychological disorders, or those at high risk for regurgitation or aspiration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved airway management techniques during otologic surgeries, enhancing patient safety and comfort.

How similar studies have performed: While the use of laryngeal masks in various surgical settings has been documented, the specific application of the BASKA mask in otologic surgery is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age group 18 - 60 years old.
2. Both genders.
3. Undergoing general anesthesia for ear surgeries in the lateral neck position (60-90 degrees) in whom BASKA mask can be a suitable device for airway management

Exclusion Criteria:

1. Patient refusal,
2. History of cardiac or respiratory disease, psychological disorders,
3. High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity,
4. neck pathology,
5. Predicted difficult airway (history of difficult airway, mouth opening \<2.5cm, Modified Mallampati class III/IV, thyro-mental distance \<6.5cm or cervical spine pathology),

Where this trial is running

Asyut, Assiut Governorate

• Main Assiut University Hospital — Asyut, Assiut Governorate, Egypt (RECRUITING)

Study contacts

• Principal investigator: Hala S Abdel-Ghaffar, MD — Assiut University
• Study coordinator: Ahmed G Esmael, MBBCH

Conditions: Airway Device