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BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

NCT ID: NCT03287752

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-14

Study Completion Date

2019-12-29

Brief Summary

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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

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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

Conditions

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Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BASKA MASK

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

BASKA MASK

Intervention Type DEVICE

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 ETT.

Endotracheal tube

Intervention Type DEVICE

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

Interventions

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BASKA MASK

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

Intervention Type DEVICE

Endotracheal tube

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

Intervention Type DEVICE

Other Intervention Names

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BASKA ETT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hala Saad Abdel-Ghaffar

Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala S Abdelghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Locations

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women health hospital, Assiut university

Asyut, Assiut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17100178

Identifier Type: -

Identifier Source: org_study_id