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CompletedNCT03287752BASKAMASKUpdated Oct 18, 2021

BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

An observational study in Ventilation, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-18.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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

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Conditions studied

  • Ventilation
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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Female patients scheduled for elective gynecological laparoscopic surgery.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • BASKA MASK

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

    Device: BASKA MASK

  • Endotracheal tube

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

    Device: Endotracheal tube

Interventions

  • DeviceBASKA MASK

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

    Also known as: BASKA

  • DeviceEndotracheal tube

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

    Also known as: ETT

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What researchers measure

Primary outcomes

  1. Peak airway pressure

    Peak airway pressure before and after abdominal inflation.

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

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Study locations

1 site
  • women health hospital, Assiut university
    Assiut, Assiut Governorate 715715, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03287752
Lead sponsor
Assiut University
Responsible party
Hala Saad Abdel-Ghaffar (Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University) — Principal investigator
First posted
Sep 19, 2017
Start date
Sep 14, 2017
Primary completion
Dec 29, 2019
Completion
Dec 29, 2019
Last update
Oct 18, 2021

Study contacts

Hala S Abdelghaffar, MD
principal investigator · Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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