BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

Ventilation Clinical Trial

— BASKAMASK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287752
• Other study ID #: 17100178
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Ventilation

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