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BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

A Prospective Randomized Comparison of the Effect of BASKA Mask Versus Endo Tracheal Tube on Respiratory Function Parameters in Patients Undergoing Gynecological Laparoscopic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03287752
Acronym
BASKAMASK
Enrollment
66
Registered
2017-09-19
Start date
2017-09-14
Completion date
2019-12-29
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

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

Interventions

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

DEVICEEndotracheal tube

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Peak airway pressure6 hours including preoperative, intraoperative and 4h after operationPeak airway pressure before and after abdominal inflation.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026