Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i

Not Applicable

• Conditions: The Baska Mask
• Interventions: Device: airway divice

• Registration Number: NCT05363566
• Lead Sponsor: Cairo University

Brief Summary

The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2022-03-19
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-06
• Last Update Posted: 2022-05-06
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	airway divice	will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)
group II	airway divice	will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)
group III (SP Air-Q) (n = 26)	airway divice	will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA)

Primary Outcome Measures

Name	Time	Method
insertion time	1 hour	To determine the time taken for insertion of the device. (It will be calculated from the time of the mask will be taken away from the patient's face till the moment of the appearance of square wave capnography upstroke with the presence of sufficient ventilation) (second )

Secondary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressures	1 hours	Oropharyngeal leak pressures (OLPs) will be recorded
Ease of device insertion	1 hours	will be graded using a five-point scoring system (4 = insertion at first attempt without tactile resistance, 3 = insertion at first attempt with little tactile resistance, 2 = insertion at first attempt with significant tactile resistance, 1 = insertion successful at second/third attempt, 0 = insertion failed at three attempts).

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt