BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery (BASKAMASK)

Assiut University

Status: Completed

Conditions: Ventilation

Treatments: Device: Endotracheal tube; Device: BASKA MASK

Study type: Observational

Funder types: Other

Identifiers

NCT03287752

17100178

Details and patient eligibility

About

The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient.

Full description

The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area.

Compared with previous versions, these modifications have made BASKA mask airway a fairly safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic surgeries

Enrollment: 66 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Sex: Female patients scheduled for elective gynecological laparoscopic surgery.

• Age: 18-60 years.
• BMI< 30kg/m2.
• ASA physical status: I-II.
• Operation: gynecological laparoscopic surgery under general anesthesia of an anticipated duration<1h.

Exclusion criteria

• Patient refusal.
• History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
• Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
• Neck pathology.
• Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance < 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance < 65 mm).
• Allergy to any of the anesthetic agents used.
• The possibility of being pregnant.
• Heavy smoker.
• Preoperative sore throat.

Trial design

66 participants in 2 patient groups

BASKA MASK

Description:

Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.

Treatment:

Device: BASKA MASK

Endotracheal tube

Description:

Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.

Treatment:

Device: Endotracheal tube