BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

Completed

• Conditions: Ventilation
• Interventions: Device: BASKA MASK; Device: Endotracheal tube

• Registration Number: NCT03287752
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2017-09-14
• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-19
• Primary Completion: 2019-12-29
• Study Completion: 2019-12-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BASKA MASK	BASKA MASK	Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.
Endotracheal tube	Endotracheal tube	Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.

Primary Outcome Measures

Name	Time	Method
Peak airway pressure	6 hours including preoperative, intraoperative and 4h after operation	Peak airway pressure before and after abdominal inflation.

Trial Locations

Locations (1)

women health hospital, Assiut university; 🇪🇬 Assiut, Assiut Governorate, Egypt