BASKAMASK: BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03287752
Collaborator
(none)
66
1
27.5
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BASKA MASK
  • Device: Endotracheal tube

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Dec 29, 2019
Actual Study Completion Date :
Dec 29, 2019

Arms and Interventions

Arm Intervention/Treatment
BASKA MASK

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

Device: BASKA MASK
Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant
Other Names:
  • BASKA
  • Endotracheal tube

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

    Device: Endotracheal tube
    Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.
    Other Names:
  • ETT
  • Outcome Measures

    Primary Outcome Measures

    1. Peak airway pressure [6 hours including preoperative, intraoperative and 4h after operation]

      Peak airway pressure before and after abdominal inflation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 women health hospital, Assiut university Assiut Assiut Governorate Egypt 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hala S Abdelghaffar, MD, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University
    ClinicalTrials.gov Identifier:
    NCT03287752
    Other Study ID Numbers:
    • 17100178
    First Posted:
    Sep 19, 2017
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 18, 2021