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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03287752
Other study ID # 17100178
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2017
Est. completion date December 29, 2019

Study information

Verified date October 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 29, 2019
Est. primary completion date December 29, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BASKA MASK
Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant
Endotracheal tube
Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.

Locations

Country Name City State
Egypt women health hospital, Assiut university Assiut Assiut Governorate

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak airway pressure Peak airway pressure before and after abdominal inflation. 6 hours including preoperative, intraoperative and 4h after operation
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