Clinical trial NCT03287752: BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery
Official title: A Prospective Randomized Comparison of the Effect of BASKA Mask Versus Endo Tracheal Tube on Respiratory Function Parameters in Patients Undergoing Gynecological Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients scheduled for elective gynecological laparoscopic surgery.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Peak airway pressure
timeFrame: 6 hours including preoperative, intraoperative and 4h after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: women health hospital, Assiut university
state: Assiut Governorate
Study officials:
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
name: Hala S Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: