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Completed

NCT Number: NCT03287752

BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

women health hospital, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BASKA MASK

Device

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

Other names: BASKA

Endotracheal tube

Device

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

Other names: ETT

Primary outcomes

  1. Peak airway pressure

    Time frame: 6 hours including preoperative, intraoperative and 4h after operation

    Peak airway pressure before and after abdominal inflation.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Acronym: BASKAMASK

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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